Cathartic ColonNCT02263443

Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery

A study testing Soap suds enema (S.S.E.), sodium chloride enema and No enema in people with Cathartic Colon and Other Surgical Procedures, run by Chiang Mai University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages Up to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cathartic Colon, Other Surgical Procedures
What is being tested?: Soap suds enema (S.S.E.), sodium chloride enema and No enema
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 330 participants
Where: 1 siteThailand
Study dates: Oct 2014to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 80 years
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Amphoe Muang, Chiang Mai, 50200

Other trials in Thailand

About this study

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

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.

Read the 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

Conditions: Cathartic Colon, Other Surgical Procedures
Being tested: Soap suds enema (S.S.E.), sodium chloride enema, No enema
Keywords: bowel preparation, gynecologic surgery, laparotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Soap suds enema (S.S.E.)Procedure or surgery
Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
sodium chloride enemaProcedure or surgery
Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
No enemaProcedure or surgery
Patients NPO groups will NPO and no bowel preparation.

Study groups in NCT02263443
Study group	Role	What they receive
Soap sus enema (S.S.E.)	Experimental	Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery. Receives: Procedure: Soap suds enema (S.S.E.)
sodium chloride enema	Experimental	Patients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery. Receives: Procedure: sodium chloride enema
no enema	Placebo comparator	Patients will receive none of bowel preparation. NPO after midnight Receives: Procedure: No enema

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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 .
Measured: 1 day after bowel preparation
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?,
Measured: 1 day before surgery and 3 day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Nov 2015

First posted13 Oct 2014 (estimated)
Study startOct 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cathartic ColonStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Care provider
Enrolment: 330 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02263443
Sponsor's protocol ID: OBG-2557-02203
Status last verified: Nov 2015
First submitted: 8 Oct 2014
Last updated: 20 Nov 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery
ClinicalTrials.gov ID: NCT02263443
Acronym / sponsor ID: OBG-2557-02203
Conditions: Cathartic Colon, Other Surgical Procedures
Keywords: bowel preparation, gynecologic surgery, laparotomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (estimated)
Lead sponsor: Chiang Mai UniversityUniversity, hospital or other
Collaborators: Prapaporn Suprasert
Study start: Oct 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 13 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (care provider)
Number of arms: 3

Arm	Type	Receives
Soap sus enema (S.S.E.)	Experimental	Procedure: Soap suds enema (S.S.E.)Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery.
sodium chloride enema	Experimental	Procedure: sodium chloride enemaPatients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery.
no enema	Placebo comparator	Procedure: No enemaPatients will receive none of bowel preparation. NPO after midnight

Who may qualify

Ages: Up to 80 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Soap sus enema (S.S.E.)
sodium chloride enemaPatients in unison enema group will Unison enema 100 ml per rectal at night before surgery	Procedure or surgery	sodium chloride enema
No enemaPatients NPO groups will NPO and no bowel preparation.	Procedure or surgery	no enema

Primary outcome

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 .
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?,

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prapaporn - Suprasert study director

Chiang Mai University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Soap suds enema (S.S.E.), sodium chloride enema and No enema in people with Cathartic Colon and Other Surgical Procedures, run by Chiang Mai University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

surgical view and bowel handling in operation (time frame: 1 day after bowel preparation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 1 Nov 2026.