Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263443
Other study ID # OBG-2557-02203
Secondary ID
Status Completed
Phase N/A
First received October 8, 2014
Last updated November 19, 2015
Start date October 2014
Est. completion date November 2015

Study information

Verified date November 2015
Source Chiang Mai University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.
sodium chloride enema
Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
No enema
Patients NPO groups will NPO and no bowel preparation.

Locations

Country Name City State
Thailand Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University Amphoe Muang Chiang Mai

Sponsors (2)

Lead Sponsor Collaborator
Chiang Mai University Prapaporn Suprasert

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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.
When the operation finished surgeon evaluate satisfaction of operation .
1 day after bowel preparation Yes
Primary 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 Yes
See also
  Status Clinical Trial Phase
Completed NCT02516566 - Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy N/A
Completed NCT02429414 - Video Double-Lumen Tube Prospective Randomized Study Phase 3
Completed NCT02248688 - Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically N/A
Completed NCT01309360 - Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine Phase 4
Completed NCT01433029 - Objective Assessment of Technical Skills in Cardiothoracic Surgery N/A
Completed NCT02494856 - Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal Phase 4
Completed NCT02450487 - Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery Phase 4
Completed NCT01726231 - Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion N/A
Completed NCT01643616 - Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique N/A
Completed NCT01580176 - Continuous GlucoseMonitor for Measurement of Blood Glucose Level N/A
Completed NCT02906969 - Colonoscopy Educational Video Upon Inner City Population N/A
Completed NCT02730026 - Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal Phase 4
Enrolling by invitation NCT02525406 - Models for Improving Operating Room Productivity: Delays, Cancellations and Pre-admission Testing
Recruiting NCT01491165 - Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis Phase 2/Phase 3
Active, not recruiting NCT03169127 - Clinical Pharmacogenetic of Ibuprofen After Lower Third Molar Surgeries Phase 4