Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery

Chiang Mai University

Status: Completed

Conditions: Cathartic Colon; Other Surgical Procedures

Treatments: Procedure: No enema; Procedure: sodium chloride enema; Procedure: Soap suds enema (S.S.E.)

Study type: Interventional

Funder types: Other

Identifiers

NCT02263443

OBG-2557-02203

Details and patient eligibility

About

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

Inclusion Criteria

1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5. Consenting participants. Exclusion Criteria

2. Pregnancy or suspected pregnancy.

3. Laparoscopic surgery

4. Do not consent to participate in research

5. Gastrointestinal infection

6. Underlying disease such as Intestinal disease, patient who cannot under going bowel preparation ,heart disease ,seizure.

7. 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.

Full description

Methods

1. 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
2. Patients information such as age, height, weight, smoking, history of surgery, number of surgeries, diagnosis that required surgery. The complete blood count and the laboratory prior to surgery record by the research team.
3. Patients do self questionnaire about symptoms such as abdominal pain or discomfort , anxiety ,nausea and vomiting etc. these are for understanding symptoms of patients before bowel preparation perform.
4. Computer-generated sequence into block for 30 person
5. Random into 3 groups by nurses .in opaque envelopes with number infront of to identify patients. Surgeon must not know what group of these patients get in.
6. Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
7. Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
8. Patients NPO groups will NPO and no bowel preparation.
9. Patients in all group are doing operative preparation such as NPO after midnight, retained foley catheter and clean abdomen and perineum before surgery. Closs matching blood.
10. In the morning before surgery , patients do self questionnaire about symptoms score such as abdominal pain or discomfort , anxiety ,nausea and vomiting etc. for symptoms of patients after bowel preparation perform last night.
11. In operation room , 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.
12. One day after surgery and before discharge from hospital patients do self questionnaire about symptoms score such as abdominal pain or discomfort , anxiety ,nausea and vomiting etc

Enrollment: 330 estimated patients

Sex: Female

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women under going laparotomy in gynecologic surgery
2. Surgeon consider not too difficult surgery.
3. Can understanding Thai language.
4. Can communicate with researcher.
5. Consenting participants.

Exclusion criteria

1. Pregnancy or suspected pregnancy.
2. Laparoscopic surgery
3. Do not consent to participate in research
4. Gastrointestinal infection
5. Underlying disease such as Intestinal disease, patient who cannot under going bowel preparation ,heart disease ,seizure.
6. 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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330 participants in 3 patient groups, including a placebo group

Soap sus enema (S.S.E.)

Experimental group

Description:

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

Treatment:

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

sodium chloride enema

Experimental group

Description:

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

Treatment:

Procedure: sodium chloride enema

no enema

Placebo Comparator group

Description:

Patients will receive none of bowel preparation. NPO after midnight

Treatment:

Procedure: No enema