(Female Sterilization) Tubal Ligation (Female Sterilization) Session III-H: Preparing for Problems and Managing Side Effects and Complications

Session Objectives By the end of the session, participants will be able to: State how complications arising from minilaparotomy procedures can be prevented Describe emergency preparedness requirements for female sterilization–related services List the components of emergency preparedness Manage common intraoperative and postoperative complications State the roles and responsibilities of the surgical team in preventing, recognizing, and managing complications of minilaparotomy. Review the session objectives.

Definitions Side effects Unintended consequences of the procedure that do not require exceptional intervention but may require attention and management Complications Unexpected consequences of the procedure, usually resulting from surgery and anesthesia, that occur within 42 days and that require intervention or management beyond what is planned or provided during routine postoperative care. Major complications Require hospitalization, surgery, blood transfusion, or treatment of life-threatening events, and may result in death. Minor complications Require intervention and management beyond what would normally be provided, but do not progress to any of the five events listed above. Ask: Describe the difference between a side effect and a complication. Allow for some contributions and click the mouse to reveal the suggested discussion points under each discuss these with the participants Explain: Side effects are unintended consequences of the procedure and medication that do not require exceptional intervention but that may require attention and management. Side effects of minilaparotomy include abdominal pain, bruising, nausea, and vomiting. Complications are unexpected consequences of the procedure, usually resulting from the surgery and anesthesia, that occur within 42 days and require intervention or management beyond what is planned or provided during routine postoperative care. Major complications require hospitalization, surgery, blood transfusion, and treatment of life-threatening events and may result in death. Minor complications require intervention and management beyond what would normally be provided but do not progress to any of the five events listed above.

Exercise Complications and Side Effects Display slide Inform participants that they will now do an exercise. Distribute among the participants the colored cards with the side effects and complications written on them; once all of the participants have received one card, ask each to read his/her card and to share with the group if it is a side effect or a complication. Correct the participants as needed, by asking other participants for different views or opinions or by providing the answer yourself, if no one offers a suggestion

Complications Female sterilization by minilaparotomy is a very safe procedure, and complications are rare and generally preventable. Overall, complication rates are generally low, estimated at between 9 and 16 per 1,000 procedures. Female sterilization deaths are rare: 1–4 per 100,000 procedures in the United States 5 per 100,000 in developing countries Show this slide and emphasize the fact that minilaparotomy is a very safe procedure if performed following the standard tasks and steps. Review the data with the participants Explain : Complication associated with minilaparotomy are rare and generally preventable. It is estimated that the rates of complications range between 9 – 16 per 1000 procedures. Mortality associated with female sterilization is also very rare and it is estimated to be below 4 per 100,000 procedures in the United States and 5 per 100,000 procedures in the developing world. Mortality rates reduced drastically following the change of anesthetic regimen used that is from general to local anesthesia. Source: EngenderHealth. 2002. Contraceptive sterilization: Global issues and trends. New York.

Prevention Early recognition Timely management All are essential. Complications Prevention Early recognition Timely management All are essential. If a postminilaparotomy client presents at the facility, Always consider her complaints related to the procedure until it is demonstrated otherwise with certitude Explain Prevention of complications enhances client safety It includes following the recommended surgical steps and observing infection prevention practices among others. If complications do occur, early recognition allows the team to respond appropriately and prevent the situation from deteriorating and becoming life threatening. It require each team member to be alert and knowledgeable and skilled to recognize impending problems. Prompt and effective management of complications saves lives. It may include timely referral of the client to a higher level facility where the condition can be managed. Managing life threatening conditions requires teamwork with immediate access to the right equipment and supplies Problems may arise after discharge and if such a client presents at any facility, It is important that any provider managing the client to always think these complaints are related to the surgical procedure until demonstrated otherwise. Ask participant to share their experiences of situations when the condition of the client had deteriorated because of lack of attention to these points and where paying attention to the above mentioned points improved the outcomes.

Client Safety Can Be Assured by the Following: Each member of the surgical team is responsible for undertaking all actions for the prevention, early recognition, and management of complications. Correct and prompt management preserves the health and perhaps the life of the client and protects the staff, the program, and the reputation of the procedure. Show this slide and review each team member’s responsibility in the prevention and management of complications. Each member of the surgical team has a role in preventing and managing complications and problems, before, during, and after the procedure. For example, the provider counseling and screening the client has the responsibility to identify any medical condition that the client may have and classify the client appropriately before advising the client on the course of action. By referring the client or delaying the procedure as needed, the provider avoids problems and complications that may arise during the procedure. On the day of the surgery, the client monitor and the circulating nurse have the responsibility of confirming that the client has followed all instructions and is ready for surgery. The preprocedure instructions include providing the premedication and asking the client to void immediately before the procedure. The surgeon has the responsibility at this stage of verifying that the client is prepared for the surgery and that she has given her informed consent. For special cases, the surgeon should have evaluated the client in advance of the procedure and, where applicable, have facilitated a review from another medical professional or have conducted an investigation, as appropriate. The circulating nurse and the surgical assistant are also responsible for ensuring that the emergency tray is available and stocked with the drugs, supplies, and equipment before surgery. Throughout the procedure, the client monitor is responsible for observing the client, monitoring her vital signs, and informing the surgeon if there are any signs of deviations. Additionally, the client monitor and other staff should be attentive and observe for any abnormal signs or responses, such as restlessness, confusion, tremors, clenching of the fist, etc. The surgeon and the surgical assistant are also responsible for observing infection prevention practices as they prepare for surgery and during performance of the procedure. In the event of a problem, the surgeon is responsible for leading the team in managing the problem. The assistant is responsible for assisting the surgeon. The circulating nurse is responsible for ensuring that the surgical team receives the required supplies from the emergency tray. The client monitor continues to observe the client and updates the other members of the surgical team and, where applicable, participates in resuscitation measures, as directed by the surgeon. Immediately after closure of the abdomen, the surgical team is responsible for ensuring a smooth recovery from the surgery and anesthesia. The client should be transferred to the recovery area, where her vital signs continue to be observed by the nurse or client monitor covering the recovery area. Any deviations of the vital signs will require alerting the doctor. Observation includes assessing the level of consciousness, whether she has any drug-related problems such as severe vomiting, excessive dizziness, not passing urine at all, confusion, or excessive/active bleeding from the wound or through the vagina. For special cases or clients with conditions such as severe obesity, previous surgical scars, or excessive anxiety, the anesthetist may be involved to provide the general anesthesia. As a member of the team, the anesthetist is responsible for ensuring the prevention of any cardiorespiratory problems and takes the lead in managing any anesthesia-related complications, with assistance from the client monitor and other members of the surgical team, as appropriate. The prior to discharge, the surgeon or client monitor has the responsibility of ensuring that the client has fully recovered from the effects of any sedation, is fully conscious, has vital signs that are the same as the preprocedure values, can walk without support, has no bleeding or undue pain at the operation site, and fully understands the postoperative instructions. After discharge, the facility staff who see clients coming back to the facility for scheduled on unscheduled visits should also be attentive, with a high index of suspicion, and should consider any problems or complains related to the surgical procedure unless otherwise confirmed. It is important for all the team members to understand that correct, prompt management of complications and problems if they arise contribute to quality of services—and more importantly, client safety. It also will save the life of the client and protect the staff and the facility from liability.

Preparing for Problems or Emergency Preparedness Administration of pain management drugs and the surgical procedure itself, although safe, may in rare instances result in life-threating complications. The surgical team should be prepared at all times to manage such emergencies. Question: What does emergency preparedness involve? Explain: All facilities that provide minilaparotomy services must have emergency management and preparedness plan. The administration of pain management drugs and or the surgical procedure although very safe, in rare instances, complications may occur which if not attended to early may be life-threatening. The surgical team should be prepared at all times to manage such emergency situations. Ask: What does emergency preparedness involve? <Allow participants to respond to the question.>

Emergency Preparedness Involves… Proper client assessment and preparation for the procedure Prevention of intraoperative and postoperative complications Routine and regular monitoring of the client’s condition Availability of emergency drugs and equipment in the procedure and recovery rooms Availability of providers skilled to recognize early signs of complications that may be life-threatening and to call for assistance and at the same time initiate emergency action A surgical team able to initiate cardiopulmonary resuscitation and stabilize the client before transfer for specialized care Mechanisms in for routinely assessing the emergency kit or equipment, drugs, and supplies Explain Emergency preparedness involves: Proper client assessment and preparation for the procedure Prevention of intra and postoperative complications Routine and regular monitoring of the client during surgery Availability of emergency drugs and equipment in the procedure and recovery rooms, All emergency equipment must be prepared for use, and in good functioning condition. A battery-operated light source should be available for back-up or focused illumination of the operative site. Availability of providers skilled to recognize early signs of complications that may be life-threatening and to call for assistance and at the same time initiate emergency action Surgical team having the ability to initiate cardio-pulmonary resuscitation and stabilize the client before transfer for specialized care Mechanisms for routinely assessing the emergency kit or equipment, drugs, and supplies should be institutionalized in routine monitoring and supervision and regularly reported to facility management.

Emergency Preparedness Involves..(cont.) A supervisory system that conducts regular emergency drills with surgical teams Staff (surgical team) who are highly knowledgeable about the drugs used for minilaparotomy and who periodically refresh their knowledge An established referral system for transferring emergency cases that cannot be managed on-site For mobile or outreach minilaparotomy services, highly skilled providers, fully equipped with supplies and equipment, and the availability of back-up support Explain: Emergency preparedness involves: The supervisory system conducts regular emergency drills with surgical teams to determine providers’ responsiveness to different emergency situations. Limitations or weaknesses identified must be promptly addressed through trainings or replacement/purchase of required resources. Staff (surgical team) are highly knowledgeable of the drugs and periodically refresh their knowledge on drugs used for minilaparotomy. Establishment of referral system for transferring emergency cases that cannot be managed on site For mobile or outreach minilaparotomy services – highly skilled providers, fully equipped with supplies and equipment and the local back-up facilities must also have the equipment, instruments, supplies, and trained staff required to handle complications following minilaparotomy.

Emergency Trolley Source: EngenderHealth 2014 Explain An emergency trolley assembled and ready for use in the procedure area or in the recovery area/room should be available at all times. Refer participants to handout no. 13 and go through the list of emergency equipment, drugs and other supplies. Explain how to use the equipment and supplies on the emergency trolley. Source: EngenderHealth 2014

Appropriate Emergency Equipment for the Recovery Room Go through the emergency equipment that have been displayed on this photo and ask the participants to add other equipment that may not be visible on this photo. Source EngenderHealth 2014

Possible Complications Intraoperative Respiratory depression due to drug overdose or allergy Cardiac arrest due to drug overdose Tubal injury Injury to the mesosalpinx Injury to the ligaments Bladder injury Bowel injury Uterine perforation Bleeding Postoperative Bleeding Infection Bladder and bowel injuries that were undetected at the time of surgery Pregnancy after the procedure Explain That major complications from tubal sterilizations are rare. Most complications are prevented by proper client screening, appropriate surgical experience, technical expertise, correct use of local anesthesia and sedation, and infection-prevention practice. Since no contraceptive method is completely safe, women should be aware of the risk of ectopic pregnancy. Click the mouse and add that that complications of minilaparotomy can happen during the procedure (intra-operatively) and after the procedure (post-operatively), and that they can be related to the surgery or to the anesthesia Ask What are some of the intraoperative and postoperative complications? The co-trainers can write their answers in a flipchart Click the mouse to reveal and review the intraoperative and postoperative complications in the slide The possible complications include the following In the intraoperative period Respiratory depression due to drug overdose or allergy Cardiac arrest due to drug overdose Tubal injury Injury to the mesosalpinx Injury to the ligaments Bladder injury Bowel injury Uterine perforation Bleeding or hemorrhage During the postoperative period, possible complications include Bleeding Infection Manifestation of problems associated bladder and bowel injuries that were undetected at the time of surgery Pregnancy after the procedure Ask if there are questions and respond as needed 13 13

Prevention of Complications Carefully screen all clients for conditions that would increase the risk of complications. Observe strict infection prevention practices. Ensure that the client has emptied her bladder Monitor the client’s vital signs during and after the procedure. Perform surgery gently, to prevent tissue damage, organ trauma, and bleeding (i.e., gentleness in opening the peritoneum, manipulating the uterine elevator, and handling the fallopian tubes). Ask What can be done to prevent each listed complication? <Allow a few responses then advance the slide show> Explain Prevention of complications involves Carefully screening all clients for conditions that would increase the risk of complications. Observing strict infection prevention practices. Constant monitoring the client Entering the abdomen carefully, ensuring the protection of the bladder and bowel. Some of the most serious minilaparotomy -related complications occur during abdominal entry. Examining a fold of the peritoneum before incising, to ensure that the bowel or omentum is not adhering to it. Suprapubic procedures: Taking care when making the suprapubic incision to avoid incising the bladder; making sure that the client’s bladder is empty will prevent this problem. Take care while opening the peritoneum to avoid injuries to the bowel. Sub-umbilical procedures: Taking care in making the sub-umbilical incision to avoid injuring the bowel or omentum, since the abdominal wall is so thin at that area. Performing the surgery gently to prevent tissue damage, organ trauma, and bleeding. This can be achieved by gently manipulating the uterine elevator, and also gently handling the abdominal structure and fallopian tubes. Do not perform any “blind” maneuver; make sure that you always visualize the structure that you try to grasp.

Prevention of Complications Handle the tubes, mesosalpinx, and tissues gently. Follow the tubes to their fimbriated ends. Apply sutures carefully and correctly; achieve hemostasis. Inspect the tissues thoroughly before closing the abdominal incision. Ensure that the client understands instructions for postoperative care. Do not treat other pathological disorders during sterilization, unless this has been planned in advance and is performed in an adequately equipped facility. Do not exceed the recommended maximum number of procedure Explain Handling the tubes, mesosalpinx, and tissues gently and applying sutures securely, to prevent bleeding. Following the tubes to their fimbriated ends and occluding them as described earlier Applying sutures carefully and correctly; always using a square surgical knot. Achieving and maintaining hemostasis. Inspecting the tissues thoroughly before closing the abdominal incision, to make sure that there is no bleeding. Ensuring that the client understands instruction for postoperative care. Do not treat other pathological disorders during sterilization, unless this has been planned in advance and is performed in an adequately equipped facility. Further, it is generally recommended that a surgical team should perform at least up to 10-12 procedure per day at the same procedure area. Such an arrangement will allow adequate time for the surgical team to prepare adequately for each client while at the same time paying attention to the abovementioned actions.

Management of Complications Requirement for effective management of complications Staff ability to recognize early symptoms of complications Staff knowledge to manage complications Staff readiness to manage complications Explain Some of the circumstances that may pre-dispose the client to complications or worsen the situation include the following: Staff failing to recognize early signs of complications Failure to make a diagnosis of the complication Failure to recognize and accept that the client’s condition may be due to the surgery leading to postponement of correct treatment Staff failing to recognize signs of drugs overdose Staff distracted from their monitoring duties by other duties Staff lacking knowledge of emergency measures Lack of emergency drugs Lack of drug antidotes Lack of staff training in the use of emergency drugs and equipment Unavailability of emergency equipment or nonfunctioning equipment Lack of clarity about staff roles and responsibilities for taking action when the doctor is absent or until the doctor arrives  

Group Exercise Symptoms/Signs Possible causes/Etiology Prevention Treatment Divide the participants into small groups of 2 participants per group. Provide each group with flipchart paper and ask them to draw four columns to be captioned “symptoms and/or signs,” “possible cause(s) or etiology,” “prevention,” and “treatment.” Use the prepared flip chart/Slide as a guide Assign specific complications to each group and ask each group to fill in the information in each column. Refer the participants to handout on minilaparotomy complication for reference. Allow 10 minutes for the groups to discuss and complete their flipchart. Ask one group to volunteer to share their work. Allow 3 minutes At the end of each submission by a group, ask the participants in plenary if they agree with what has been presented or if they have something to add. Correct any information as needed After all groups have presented distribute the handout on Minilaparotomy Complications (handout #16) and quickly go through all the complications listed, covering the possible cause, preventive and treatment of the complication.

Mortality Associated with Female Sterilization Death within 42 days of a sterilization procedure, or death resulting from a complication that occurs before the 42nd postoperative day Attributable death Mortality resulting from complication(s) of the operation and/or anesthesia Nonattributable death Mortality occurring after the operation that is not causally associated with the operation and/or anesthesia, their complication, or their management. Contributing factors Health conditions present at the moment of the surgery that could have been worsened by the surgery or the anesthesia, resulting in unforeseen complications or death Explain terminologies used to describe mortality associated with female sterilization Definition of mortality associated with female sterilization is Death within 42 days of a sterilization procedure, or death resulting from a complication that occurs before 42 days postoperative The death may be as a direct result of the procedure caused by surgical or anesthetic complications or it may occur after the operation but as a result of a condition that is not associated with the anesthetic or operation related complications such deaths are further classified as attributable and non attributable deaths Attributable death Mortality resulting from complication(s) of the operation and/or anesthesia, Non-attributable death Mortality occurring after the operation that is not causally associated with the operation and/or anesthesia, their complication, or their management.

Mortality Associated with Female Sterilization (cont.) Preventable Death could have been prevented by the observation of such elements of care as proper screening, correct surgical technique, proper anesthesia regimen, or good care of complications. Not preventable Death could not have been prevented, as all proper care was provided and complications or death could not have been foreseen. Ask the participants to share their experiences in managing or handling mortality associated with such surgical or medical procedures Allow some sharing of experiences. Ensure that the following points are covered during the discussions Facility guidelines on how to handle such mortality cases should be followed Relevant staff in the leadership of the institution or organization must carefully analyze every death to determine the following: Whether the death was attributable to the minilaparotomy Whether the death was attributable to the anesthesia regimen The contributing causes Whether staff could have anticipated or prevented any of the factors in the death Corrective measures needed to prevent a similar death