Colorectal DiseasesOLAX-CRCNCT07820696
Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
A study testing Oral Laxative and Rectal Enema in people with Colorectal Diseases and Mechanical Bowel Preparation, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Diseases, Mechanical Bowel Preparation
- What is being tested?
- Oral Laxative and Rectal Enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2026to 22 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective laparoscopic colorectal resection
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Who cannot join
- Requirement for emergency surgery
- Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
- Anticipated extensive intra-abdominal adhesions
- Active inflammatory bowel disease
- Pregnancy
- Serious systemic disease constituting a contraindication to oral laxative use
- Inability to perform standardized intraoperative small-bowel diameter measurements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Türkiye, Van Training and Research Hospital
Van, Van, 65300
İbrahim Doğan, +905313884966, dogan_203@hotmail.com
About this study
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty. Adult patients scheduled for elective laparoscopic colorectal resection will be randomly assigned to receive either oral laxative plus rectal enema preparation or rectal enema preparation alone. During surgery, the diameters of the jejunum and ileum will be measured using a standardized method. The study will also compare operative difficulty, bowel manipulation time, operation duration, need for additional ports, conversion to open surgery, intraoperative complications, blood loss, and early postoperative outcomes between the two groups. The findings may help clarify whether oral laxative use influences intraoperative conditions during laparoscopic colorectal surgery.
Read the detailed description
Mechanical bowel preparation is commonly used before elective colorectal surgery. Although its effects on postoperative outcomes have been widely investigated, limited evidence is available regarding the effect of oral laxatives on intraoperative small-bowel distension and technical difficulty during laparoscopic colorectal surgery. Increased intraluminal fluid following oral laxative administration may lead to small-bowel distension, potentially impairing surgical exposure and increasing the need for bowel manipulation.
In this study, small-bowel diameter will be assessed intraoperatively using a standardized measurement method after laparoscopic access and establishment of pneumoperitoneum. Jejunal diameter will be measured approximately 50 cm distal to the ligament of Treitz, and ileal diameter approximately 20 cm proximal to the ileocecal valve. Measurements will be performed in the transverse plane without applying mesenteric tension and, when feasible, the mean of two measurements will be recorded. At the end of the operation, the operating surgeon will assess overall operative difficulty using a Likert-type scale ranging from very easy to very difficult. This pilot study is intended to provide preliminary evidence for the design of future adequately powered studies and to support the evaluation of current bowel-preparation practices.
- Conditions
- Colorectal Diseases, Mechanical Bowel Preparation
- Being tested
- Oral Laxative, Rectal Enema
- Keywords
- Colorectal Surgery, Mechanical Bowel Preparation, Oral Laxative, Randomized Controlled Trial, Laparoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral LaxativeDrug
Participants assigned to the experimental arm will receive an oral laxative as part of preoperative mechanical bowel preparation, in addition to a rectal enema, before elective laparoscopic colorectal surgery. The oral laxative will be administered according to the institution's standard preoperative bowel preparation protocol.
Rectal EnemaDrug
Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery. Participants in the comparator arm will receive the rectal enema without an oral laxative.
| Study group | Role | What they receive |
|---|---|---|
| Oral Laxative Plus Rectal Enema | Experimental | Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery. Receives: Drug: Oral Laxative; Drug: Rectal Enema |
| Rectal Enema Alone | Active comparator | Participants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery. Receives: Drug: Rectal Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Jejunal Diameter
Jejunal diameter will be measured in centimeters approximately 50 cm distal to the ligament of Treitz, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
Measured: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Intraoperative Ileal Diameter
Ileal diameter will be measured in centimeters approximately 20 cm proximal to the ileocecal valve, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
Measured: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Secondary outcomes (15)
Operative Difficulty Score
Overall operative difficulty will be assessed by the operating surgeon at the end of the procedure using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, and 5 = very difficult. Higher scores indicate greater operative difficulty.
Measured: At the end of surgery, on the day of the procedure
Estimated Intraoperative Blood Loss
The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.
Measured: Intraoperatively, on the day of surgery
Incidence of Intraoperative Serosal Injury
The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.
Measured: Intraoperatively, on the day of surgery
Incidence of Intraoperative Organ Injury
The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.
Measured: Intraoperatively, on the day of surgery
Incidence of Intraoperative Bleeding Requiring Intervention
The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.
Measured: Intraoperatively, on the day of surgery
Requirement for an Additional Laparoscopic Port
The number of participants in whom placement of at least one additional laparoscopic port beyond the planned port configuration is required to complete the procedure.
Measured: Intraoperatively, on the day of surgery
Conversion From Laparoscopic to Open Surgery
The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.
Measured: Intraoperatively, on the day of surgery
Incidence of Any Postoperative Complication Within 30 Days
The number of participants who experience at least one surgery-related postoperative complication within 30 days after surgery. Each participant will be counted once, regardless of the number of complications experienced.
Measured: From the day of surgery through postoperative day 30
Incidence of Anastomotic Leakage Within 30 Days
The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.
Measured: From the day of surgery through postoperative day 30
Incidence of Surgical Site Infection Within 30 Days
The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.
Measured: From the day of surgery through postoperative day 30
Incidence of Postoperative Ileus Within 30 Days
The number of participants who develop postoperative ileus within 30 days after surgery, as documented in the medical record based on delayed recovery or interruption of gastrointestinal function.
Measured: From the day of surgery through postoperative day 30
Time Required for Bowel Manipulation and Displacement
The time required to manipulate the bowel and displace it from the operative field during surgery.
Measured: Intraoperatively, on the day of surgery
Time Required for Intraoperative Bowel Diameter Measurements
The time required to perform intraoperative measurements of the jejunal and ileal diameters.
Measured: Intraoperatively, on the day of surgery
Time Required to Complete the Anastomosis
The time from initiation of anastomosis construction to completion of the anastomosis during surgery.
Measured: Intraoperatively, on the day of surgery
Total Operation Time
The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.
Measured: Intraoperatively, on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start22 May 2026
- Primary completion22 May 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving either oral laxative plus rectal enema preparation or rectal enema preparation alone before elective laparoscopic colorectal surgery. Each participant will remain in the assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM DOGAN, Van Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820696
- Sponsor's protocol ID
- 2026/05-02
- Acronym
- OLAX-CRC
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
- ClinicalTrials.gov ID
- NCT07820696
- Acronym / sponsor ID
- OLAX-CRC / 2026/05-02
- Conditions
- Colorectal Diseases, Mechanical Bowel Preparation
- Keywords
- Colorectal Surgery, Mechanical Bowel Preparation, Oral Laxative, Randomized Controlled Trial, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Van Training and Research HospitalOther government
- Study start
- 22 May 2026 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- 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.
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty. Adult patients scheduled for elective laparoscopic colorectal resection will be randomly assigned to receive either oral laxative plus rectal enema preparation or rectal enema preparation alone. During surgery, the diameters of the jejunum and ileum will be measured using a standardized method. The study will also compare operative difficulty, bowel manipulation time, operation duration, need for additional ports, conversion to open surgery, intraoperative complications, blood loss, and early postoperative outcomes between the two groups. The findings may help clarify whether oral laxative use influences intraoperative conditions during laparoscopic colorectal surgery.
Detailed description
Mechanical bowel preparation is commonly used before elective colorectal surgery. Although its effects on postoperative outcomes have been widely investigated, limited evidence is available regarding the effect of oral laxatives on intraoperative small-bowel distension and technical difficulty during laparoscopic colorectal surgery. Increased intraluminal fluid following oral laxative administration may lead to small-bowel distension, potentially impairing surgical exposure and increasing the need for bowel manipulation.
In this study, small-bowel diameter will be assessed intraoperatively using a standardized measurement method after laparoscopic access and establishment of pneumoperitoneum. Jejunal diameter will be measured approximately 50 cm distal to the ligament of Treitz, and ileal diameter approximately 20 cm proximal to the ileocecal valve. Measurements will be performed in the transverse plane without applying mesenteric tension and, when feasible, the mean of two measurements will be recorded. At the end of the operation, the operating surgeon will assess overall operative difficulty using a Likert-type scale ranging from very easy to very difficult. This pilot study is intended to provide preliminary evidence for the design of future adequately powered studies and to support the evaluation of current bowel-preparation practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving either oral laxative plus rectal enema preparation or rectal enema preparation alone before elective laparoscopic colorectal surgery. Each participant will remain in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Oral Laxative Plus Rectal Enema | Experimental | Drug: Oral Laxative, Drug: Rectal EnemaParticipants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery. |
| Rectal Enema Alone | Active comparator | Drug: Rectal EnemaParticipants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Scheduled for elective laparoscopic colorectal resection
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Key exclusion criteria (7 listed)
- Requirement for emergency surgery
- Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
- Anticipated extensive intra-abdominal adhesions
- Active inflammatory bowel disease
- Pregnancy
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 |
|---|---|---|
| Oral LaxativeParticipants assigned to the experimental arm will receive an oral laxative as part of preoperative mechanical bowel preparation, in addition to a rectal enema, before elective laparoscopic colorectal surgery. The oral laxative will be administered according to the institution's standard preoperative bowel preparation protocol. | Drug | Oral Laxative Plus Rectal Enema |
| Rectal EnemaParticipants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery. Participants in the comparator arm will receive the rectal enema without an oral laxative. | Drug | Oral Laxative Plus Rectal Enema, Rectal Enema Alone |
Primary outcome
Intraoperative Jejunal Diameter
Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Jejunal diameter will be measured in centimeters approximately 50 cm distal to the ligament of Treitz, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
Intraoperative Ileal Diameter
Time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Ileal diameter will be measured in centimeters approximately 20 cm proximal to the ileocecal valve, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension. When feasible, two measurements will be obtained and their mean will be recorded.
15 secondary outcomes
Operative Difficulty Score
Time frame: At the end of surgery, on the day of the procedure
Estimated Intraoperative Blood Loss
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Serosal Injury
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Organ Injury
Time frame: Intraoperatively, on the day of surgery
Incidence of Intraoperative Bleeding Requiring Intervention
Time frame: Intraoperatively, on the day of surgery
Requirement for an Additional Laparoscopic Port
Time frame: Intraoperatively, on the day of surgery
Conversion From Laparoscopic to Open Surgery
Time frame: Intraoperatively, on the day of surgery
Incidence of Any Postoperative Complication Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Incidence of Anastomotic Leakage Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Incidence of Surgical Site Infection Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Incidence of Postoperative Ileus Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Time Required for Bowel Manipulation and Displacement
Time frame: Intraoperatively, on the day of surgery
Time Required for Intraoperative Bowel Diameter Measurements
Time frame: Intraoperatively, on the day of surgery
Time Required to Complete the Anastomosis
Time frame: Intraoperatively, on the day of surgery
Total Operation Time
Time frame: Intraoperatively, on the day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Laxative and Rectal Enema in people with Colorectal Diseases and Mechanical Bowel Preparation, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İbrahim Doğan (+905313884966, dogan_203@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Jejunal Diameter (time frame: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum). 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?
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 15 Sep 2026.