Bowel Function After Minimally Invasive Hysterectomy

NCT04263896 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB19-0436
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nonsteroidal anti-inflammatory drugs (NSAID) use and anatomic manipulation. There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function. The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score

  Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.

  change in score from 10 days pre-operation to 7 days post-operation

• Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score

  Patient assessment of constipation quality of life (PAC-QOL) - PAC-Qol is a self-reported questionnaire, was used to measure the quality of life of patients.9 The validated PAC-QoL is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. The first three subscales are used to assess the patient dissatisfaction index, with an overall score ranging from 0 to 96 (where lower scores correspond to better quality of life). The satisfaction subscale includes four items with a global score ranging from 0 to 16, so that each patient's self-reported definitive outcome is defined as either poor (0-4), fairly good (5-8), good (9-12), or excellent (13-16).

  change in score from 10 days pre-operation to 7 days post-operation

Secondary Outcomes (3)

• Visual Analog Scale for Pain Management

  The 7 days after surgery (surgery is D0)

• Pain Medication Consumption Tracking by Participant

  The 7 days after surgery (surgery is D0)

• Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score

  7 days before surgery

Study Arms (2)

Participants receiving pre-operative laxative

EXPERIMENTAL

Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.

Drug: Polyethylene Glycol 3350

Participants not receiving pre-operative laxative

NO INTERVENTION

Participants will not be given any laxatives.

Interventions

Polyethylene Glycol 3350 DRUG

Participants will take 1 17g pack per day for 10 days preceding surgery.

Also known as: Miralax

Participants receiving pre-operative laxative

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
• Able to understand the consenting process and willing to participate in study

You may not qualify if:

• Planned laparotomy
• Emergent surgery
• Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
• Planned bowel surgery
• Presence of colostomy
• Inability to consent
• Medical problems as follows:
• Chronic Kidney Disease (Cr: \> 1.2 mg/dL)
• Insulin-Dependent Diabetes Mellitus
• Cardiac disease
• Gastric ulcers
• Difficulty swallowing or esophageal stricture
• Persistent nausea or vomiting
• Signs or symptoms of a small bowel obstruction

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (17)

• Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.

  PMID: 20207340 BACKGROUND

• Edenfield AL, Siddiqui NY, Wu JM, Dieter AA, Garrett MA, Visco AG. Polyethylene Glycol 3350 and Docusate Sodium Compared With Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):543-9. doi: 10.1097/AOG.0000000000001565.

  PMID: 27500338 RESULT

• Clarke A, Black N, Rowe P, Mott S, Howle K. Indications for and outcome of total abdominal hysterectomy for benign disease: a prospective cohort study. Br J Obstet Gynaecol. 1995 Aug;102(8):611-20. doi: 10.1111/j.1471-0528.1995.tb11398.x.

  PMID: 7654638 RESULT

• Mythen MG. Postoperative gastrointestinal tract dysfunction: an overview of causes and management strategies. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S66-71. doi: 10.3949/ccjm.76.s4.11.

  PMID: 19880839 RESULT

• Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001 Nov;182(5A Suppl):11S-18S. doi: 10.1016/s0002-9610(01)00782-6.

  PMID: 11755892 RESULT

• Iwanoff C, Giannopoulos M, Salamon C. Follow-up postoperative calls to reduce common postoperative complaints among urogynecology patients. Int Urogynecol J. 2019 Oct;30(10):1667-1672. doi: 10.1007/s00192-018-3809-x. Epub 2018 Nov 9.

  PMID: 30413866 RESULT

• Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.

  PMID: 20946445 RESULT

• Spence-Jones C, Kamm MA, Henry MM, Hudson CN. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and urinary stress incontinence. Br J Obstet Gynaecol. 1994 Feb;101(2):147-52. doi: 10.1111/j.1471-0528.1994.tb13081.x.

  PMID: 8305390 RESULT

• Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.

  PMID: 15902178 RESULT

• Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002 Jul;57(7):462-7. doi: 10.1097/00006254-200207000-00023.

  PMID: 12172223 RESULT

• Hur HC, Lightfoot M, McMillin MG, Kho KA. Vaginal cuff dehiscence and evisceration: a review of the literature. Curr Opin Obstet Gynecol. 2016 Aug;28(4):297-303. doi: 10.1097/GCO.0000000000000294.

  PMID: 27310715 RESULT

• McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529.

  PMID: 22453316 RESULT

• Marciniak CM, Toledo S, Lee J, Jesselson M, Bateman J, Grover B, Tierny J. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial. World J Gastroenterol. 2014 Nov 21;20(43):16323-33. doi: 10.3748/wjg.v20.i43.16323.

  PMID: 25473191 RESULT

• Iyigun E, Ayhan H, Demircapar A, Tastan S. Impact of preoperative defecation pattern on postoperative constipation for patients undergoing cardiac surgery. J Clin Nurs. 2017 Feb;26(3-4):495-501. doi: 10.1111/jocn.13473. Epub 2016 Aug 15.

  PMID: 27404560 RESULT

• Dipalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007 Jul;102(7):1436-41. doi: 10.1111/j.1572-0241.2007.01199.x. Epub 2007 Mar 31.

  PMID: 17403074 RESULT

• Yiannakou Y, Tack J, Piessevaux H, Dubois D, Quigley EMM, Ke MY, Da Silva S, Joseph A, Kerstens R. The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1103-1111. doi: 10.1111/apt.14349. Epub 2017 Oct 6.

  PMID: 28983926 RESULT

• Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.

  PMID: 10522604 RESULT

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of this study include a greater than expected dropout rate. With an anticipated 20% drop-out rate, we planned to include 80 patients in our statistical analysis. However, only 50-65 patients (depending on the outcome measure) had completed enough of the study materials to be included in the analysis, so our conclusions are under-powered. Furthermore, this was a non-blinded study, which may have contributed to a reporting bias among participants.

Results Point of Contact

• Title: Dr. Sandra Laveaux
• Organization: University of Chicago

slaveaux@bsd.uchicago.edu

773-702-6118

Study Officials

• Diane Glass, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following enrollment subjects will be randomized into the intervention/treatment arm and control arm through a randomizing process in the investigator's database.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: February 11, 2020
• Study Start: August 28, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 9, 2025
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)