Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery

NCT02263443 | Completed

• 1 other identifier: OBG-2557-02203
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University. In our study we divide patients into 3 groups ,First group patients doing Soap suds enema (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups and lower side effects in patients in no bowel preparation group. Research objectives

1. 1.Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of soap suds enema group, sodium chloride enema group and the NPO group in patients under going exploratory laparotomy in gynecologic surgery.
2. 2.Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.
3. 3.Pregnancy or suspected pregnancy.
4. 4.Laparoscopic surgery
5. 5.Do not consent to participate in research
6. 6.Gastrointestinal infection
7. 7.Underlying disease such as Intestinal disease, patient who cannot under going bowel preparation ,heart disease ,seizure.
8. 8.Surgeon consider difficult surgery such as fixed mass or uterus with others organs from per vaginal examination or very huge mass or history of difficult surgery or history of severe adhesion in abdominal cavity.

Conditions

Cathartic Colon; Other Surgical Procedures

Keywords

bowel preparation; gynecologic surgery; laparotomy

Outcome Measures

Primary Outcomes (2)

• surgical view and bowel handling in operation

  surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse and after operation finish surgeon evaluate satisfaction of operation. Evaluation in operation 1. In operation room , surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse using visual analog scale score 0 to 10 that depend on surgical view and bowel handling, 0 is the worst surgical view and hardest bowel handling and 10 for extremely good surgical view and easiest bowel handling. 2. When the operation finished surgeon evaluate satisfaction of operation .

  1 day after bowel preparation

• Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.

  Patients self answers Questionnaire about symptoms by visual analog scale score 0 to 10 that depend on severity of symptoms 0 is no symptoms and 10 most severe symptoms. Symptoms including headache, nausea, vomiting, thirsty, fatique, anxious, discomfort, abdominal pain , bloating, insomnia, ashamed, fecal incontinence. Additional questions in morning before surgery are Do you feelng discomfort from these bowel preparation?, do you want to do the same bowel preparation method if you have to do next operation? and do you want to change to other methods?,

  1 day before surgery and 3 day after surgery

Study Arms (3)

Soap sus enema (S.S.E.)

EXPERIMENTAL

Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery.

Procedure: Soap suds enema (S.S.E.)

sodium chloride enema

EXPERIMENTAL

Patients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery.

Procedure: sodium chloride enema

no enema

PLACEBO COMPARATOR

Patients will receive none of bowel preparation. NPO after midnight

Procedure: No enema

Interventions

Soap suds enema (S.S.E.) PROCEDURE

Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.

Soap sus enema (S.S.E.)

sodium chloride enema PROCEDURE

Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery

sodium chloride enema

No enema PROCEDURE

Patients NPO groups will NPO and no bowel preparation.

no enema

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women under going laparotomy in gynecologic surgery
• Surgeon consider not too difficult surgery.
• Can understanding Thai language.
• Can communicate with researcher.
• Consenting participants.

You may not qualify if:

• Pregnancy or suspected pregnancy.
• Laparoscopic surgery
• Do not consent to participate in research
• Gastrointestinal infection
• Underlying disease such as Intestinal disease, patient who cannot under going bowel preparation ,heart disease ,seizure.
• Surgeon consider difficult surgery such as fixed mass or uterus with others organs from per vaginal examination or very huge mass or history of difficult surgery or history of severe adhesion in abdominal cavity.

Sponsors & Collaborators

• Chiang Mai University: lead
• Prapaporn Suprasert: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University

Amphoe Muang, Chiang Mai, 50200, Thailand

Location

Study Officials

• Prapaporn - Suprasert

  Chiang Mai University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

TH (1)