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Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT02263443
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Prapaporn Suprasert
Information provided by (Responsible Party):
Wasakorn Suadee, Chiang Mai University

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.

Condition or disease Intervention/treatment Phase
Cathartic Colon Other Surgical Procedures Procedure: Soap suds enema (S.S.E.) Procedure: sodium chloride enema Procedure: No enema Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery
Study Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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.
Procedure: Soap suds enema (S.S.E.)
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.
Procedure: sodium chloride enema
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
Procedure: No enema
Patients NPO groups will NPO and no bowel preparation.




Primary Outcome Measures :
  1. 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. 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 .

  2. 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?,




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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263443


Locations
Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Amphoe Muang, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Prapaporn Suprasert
Investigators
Study Director: Prapaporn - Suprasert Chiang Mai University

Responsible Party: Wasakorn Suadee, M.D., Chiang Mai University
ClinicalTrials.gov Identifier: NCT02263443     History of Changes
Other Study ID Numbers: OBG-2557-02203
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Wasakorn Suadee, Chiang Mai University:
bowel preparation
gynecologic surgery
laparotomy