Clinical trial NCT02263443: Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery
Official title: Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cathartic Colon
Other Surgical Procedures
Keywords: bowel preparation
gynecologic surgery
laparotomy
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: Prapaporn Suprasert
First posted: 2014-10-13
Enrollment: 330
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: surgical view and bowel handling in operation
timeFrame: 1 day after bowel preparation
measure: Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.
timeFrame: 1 day before surgery and 3 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amphoe Muang
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Chiang Mai University
name: Prapaporn - Suprasert
role: STUDY_DIRECTOR
References: