Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
97 participants
INTERVENTIONAL
2019-08-28
2025-06-09
Brief Summary
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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.
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Detailed Description
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Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.
Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).
At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Participants receiving pre-operative laxative
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.
Polyethylene Glycol 3350
Participants will take 1 17g pack per day for 10 days preceding surgery.
Participants not receiving pre-operative laxative
Participants will not be given any laxatives.
No interventions assigned to this group
Interventions
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Polyethylene Glycol 3350
Participants will take 1 17g pack per day for 10 days preceding surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand the consenting process and willing to participate in study
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Diane Glass, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB19-0436
Identifier Type: -
Identifier Source: org_study_id
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