Do we need mechanical bowel preparation before benign gynecologic laparoscopic surgeries? A randomized, single blind, controlled trial Dr. Burak Karadağ & Dr. Barış Mülayim Department of Obstetrics and Gynecology Antalya Education and Research Hospital

AIM oral sodium phosphate sodium phosphate enema no mechanical bowel preparation

AIM Patient’s preoperative overall discomfort The utility of mechanical bowel preparation (MBP) when removing large uteri Patients who have a high BMI. And we also analyzed

Methods This trial was conducted between June 2016 and December 2016 at Antalya Education and Research Hospital.

Exclusion criteria included Methods Non-pregnant women ages 18-80 years undergoing elective laparoscopic surgery for benign gynecologic conditions were included. Inability to perform oral or enema agent Unable to complete MBP regimen Suspicion of malignancy or pregnancy Associated non-gynecological surgical pathologies Suspicion of deep infiltrative endometriosis Conversion to laparotomy Exclusion criteria included

Methods Oral NaP group were instructed to ingest 45 mL of NaPsolution (from B.T., Yenişehir Laboratories, Ankara, Turkey) in the evening on the day before surgery. NaP enema group were instructed to self-administer a single 177 mL NaP enema (from B.T., Yenişehir Laboratories, Ankara, Turkey) rectally at bedtime the evening before the surgery. Fasting only group and both MBP groups were allowed a clear liquid diet in the evening on the day before surgery and were not to ingest anything by mouth including liquids after midnight.

Methods All surgical procedures were carried out by the same primary surgeon. At the end of surgery, the primary surgeon completed a questionnaire, which asked him to rate intra-operative visualization of the surgical field, ease of bowel handling and overall ease of the surgery. A Five-point scale; visual analog scale (VAS) was used for this evaluation (poor/very difficult; 1, sufficient/ moderately difficult; 2, medium /average difficulty; 3, good / easy; 4, excellent/ very easy; 5). Finally the surgeon was asked to guess whether the patient had performed MBP or not.

Methods The next morning (before surgery), all patients were interviewed by an independent investigator about preoperative overall discomfort levels with a 5-point scale, using VAS for this evaluation Finally, patients in mechanical bowel preparation groups (oral NaP and NaP enema) were asked if they would recommend the type of mechanical bowel preparation to other patients undergoing the same procedure.

Results Oral NaP (n=85) NaP Enema (n=88) Fasting Only (n=89) p Age (y) 40.8±13.2 41.4±10.4 41.1±11.6 0.799 Body mass index (kg/m2) 27.1±5.5 27±5.2 25.9±5.3 0.155 Parity 1 (0-6) 2 (0-8) 2 (0-9) 0.191 Medical history None 73 (85.9%) 73 (83%) 72 (80.9%) 0.544 HT 7 (8.2%) 11 (12.5%) 10 (11.2%) DM 3 (3.5%) 4 (4.5%) 3 (3.4%) HT+DM 2 (2.4%) - Prior abdominal surgery 29 (34.1%) 30 (34.1%) 32 (36%) 0.957 Surgical procedure Hysterectomy 40 (47.1%) 45 (51.1%) 40 (44.9%) 0.942 Cystectomy 9 (10.6%) 9 (10.2%) 12 (13.5%) Salpingo-oophorectomy 2 (2.2%) Diagnostic 6 (7.1%) 11 (12.4%) Myomectomy 8 (9.4%) 6 (6.8%) 7 (7.9%) Sacrocolpopexy Ovarian drilling 13 (15.3%) 8 (9.1%) Operative time (min) 71.6±45.6 82.5±49.8 79.8±54.6 0.280 Estimated blood loss( mL) 76.4±95.9 108.3±123 103.1±131.2 0.091 Hemoglobin difference (g/dL) 1.53±0.98 1.72±0.95 1.58±2.1 0.149 Uterus weight (gr) 344.4±210 334.6±255.8 346.4±216.8 0.445 Length of stay (h) 46.5±17.7 54±23 51.5±21 0.104

Surgeon questionnaire scores using VAS. Results Oral NaP (n=85) NaP Enema (n=88) Fasting Only (n=89) p Intraoperative visualization of the surgical field 4 (1-5) 0.926 Ease of bowel handling 3 (1-5) 0.400 Overall ease of the surgery 0.634 Surgeon questionnaire scores using VAS.

Results BMI<30kg/m2 BMI≥30kg/m2 Oral NaP (n=65) NaP Enema (n=64) Fasting Only (n=69) p‡ (n=20) Enema (n=24) Only (n=20) Intraoperative visualization of the surgical field 4 (2-5) 4 (1-5) 0.964 3 (1-5) 0.840 Ease of bowel handling 0.508 3.5 (2-5) 3 (2-5) 0.560 Overall ease of the surgery 0.544 0.692 Surgeon questionnaire scores using VAS when analyzed according to the BMI

Results <350gr ≥350gr Oral NaP (n=65) NaP Enema (n=64) Fasting Only (n=69) p‡ (n=20) Enema (n=24) Only (n=20) Intraoperative visualization of the surgical field 4 (1-5) 3 (2-5) 0.937 4.5 (2-5) 4 (2-5) 0.261 Ease of bowel handling 3.5 (1-5) 0.521 0.267 Overall ease of the surgery 3.5 (1-5) 0.869 0.264 Surgeon questionnaire scores using VAS when analyzed according to the uterine weight in patients underwent total laparoscopic hysterectomy

Results Primary surgeon was correct in his assessment of the use of MBP 51.5% of the time.

Results The preoperative symptoms investigated among all patients, using a VAS regarding overall discomfort was better in NaP enema group 3 (1-5) compared with oral NaP group 3 (1-5) but the difference was not significant (p=0.189). The preoperative overall discomfort score was significantly better in fasting only group 4 (3-5) when compared with oral NaP and NaP enema groups (p<0.001). 64% of patients in oral NaP group and 68% of patients in NaP enema group reported that they would recommend their use to a friend undergoing the same procedure.

Conclusion MBP using oral sodium phosphate and sodium phosphate enema and no MBP patients have similar effect with respect to intra-operative visualization of the surgical field, ease of bowel handling and overall ease of the surgery. Moreover there is no benefit of MBP when removing large uteri or operating on patients who have a high BMI.

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