- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263443
Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery
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
- 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.
- 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
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods
- 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
- 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.
- 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.
- Computer-generated sequence into block for 30 person
- 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.
- Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
- Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
- Patients NPO groups will NPO and no bowel preparation.
- 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.
- 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.
- 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.
- 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chiang Mai
-
Amphoe Muang, Chiang Mai, Thailand, 50200
- Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women under going laparotomy in gynecologic surgery
- Surgeon consider not too difficult surgery.
- Can understanding Thai language.
- Can communicate with researcher.
- Consenting participants.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soap sus enema (S.S.E.)
Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery.
|
Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
|
Experimental: sodium chloride enema
Patients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery.
|
Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
|
Placebo Comparator: no enema
Patients will receive none of bowel preparation.
NPO after midnight
|
Patients NPO groups will NPO and no bowel preparation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical view and bowel handling in operation
Time Frame: 1 day after bowel preparation
|
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 day after bowel preparation
|
Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.
Time Frame: 1 day before surgery and 3 day after surgery
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Prapaporn - Suprasert, Chiang Mai University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OBG-2557-02203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Other Surgical Procedures
-
M.D. Anderson Cancer CenterCompletedOther Surgical ProceduresUnited States
-
Drexel UniversityCompletedOther Surgical Procedures
-
Asan Medical CenterCompletedOther Surgical Procedures
-
Susanne FrankenhauserCompletedOther Surgical ProceduresGermany
-
M.D. Anderson Cancer CenterE.T. View Medical LtdCompleted
-
Helios Research CenterCompletedOther Surgical Procedures
-
University of Toledo Health Science CampusEnrolling by invitationOther Surgical ProceduresUnited States
-
Bagcilar Training and Research HospitalCompletedOther Surgical ProceduresTurkey
-
Helios Research CenterCompletedOther Surgical Procedures
-
Erol KaraaslanNot yet recruitingOther Complications of Surgical and Medical Procedures