Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty (OLAX-CRC)

10. september 2026 opdateret af: IBRAHIM DOGAN, Van Training and Research Hospital
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Van
      • Van, Van, Tyrkiet (Türkiye), 65300
        • Rekruttering
        • University of Health Sciences Türkiye, Van Training and Research Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Oral Laxative Plus Rectal Enema
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.
Medicin: Oral Laxative
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.
Medicin: Rectal Enema
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.
Aktiv komparator: Rectal Enema Alone
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.
Medicin: Rectal Enema
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative Jejunal Diameter
Tidsramme: 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.
Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
Intraoperative Ileal Diameter
Tidsramme: 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.
Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Operative Difficulty Score
Tidsramme: At the end of surgery, on the day of the procedure
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.
At the end of surgery, on the day of the procedure
Estimated Intraoperative Blood Loss
Tidsramme: Intraoperatively, on the day of surgery
The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.
Intraoperatively, on the day of surgery
Incidence of Intraoperative Serosal Injury
Tidsramme: Intraoperatively, on the day of surgery
The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.
Intraoperatively, on the day of surgery
Incidence of Intraoperative Organ Injury
Tidsramme: Intraoperatively, on the day of surgery
The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.
Intraoperatively, on the day of surgery
Incidence of Intraoperative Bleeding Requiring Intervention
Tidsramme: Intraoperatively, on the day of surgery
The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.
Intraoperatively, on the day of surgery
Requirement for an Additional Laparoscopic Port
Tidsramme: Intraoperatively, on the day of surgery
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.
Intraoperatively, on the day of surgery
Conversion From Laparoscopic to Open Surgery
Tidsramme: Intraoperatively, on the day of surgery
The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.
Intraoperatively, on the day of surgery
Incidence of Any Postoperative Complication Within 30 Days
Tidsramme: From the day of surgery through postoperative day 30
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.
From the day of surgery through postoperative day 30
Incidence of Anastomotic Leakage Within 30 Days
Tidsramme: From the day of surgery through postoperative day 30
The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.
From the day of surgery through postoperative day 30
Incidence of Surgical Site Infection Within 30 Days
Tidsramme: From the day of surgery through postoperative day 30
The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.
From the day of surgery through postoperative day 30
Incidence of Postoperative Ileus Within 30 Days
Tidsramme: From the day of surgery through postoperative day 30
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.
From the day of surgery through postoperative day 30
Time Required for Bowel Manipulation and Displacement
Tidsramme: Intraoperatively, on the day of surgery
The time required to manipulate the bowel and displace it from the operative field during surgery.
Intraoperatively, on the day of surgery
Time Required for Intraoperative Bowel Diameter Measurements
Tidsramme: Intraoperatively, on the day of surgery
The time required to perform intraoperative measurements of the jejunal and ileal diameters.
Intraoperatively, on the day of surgery
Time Required to Complete the Anastomosis
Tidsramme: Intraoperatively, on the day of surgery
The time from initiation of anastomosis construction to completion of the anastomosis during surgery.
Intraoperatively, on the day of surgery
Total Operation Time
Tidsramme: Intraoperatively, on the day of surgery
The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.
Intraoperatively, on the day of surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Van Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. maj 2026

Primær færdiggørelse (Anslået)

22. maj 2027

Studieafslutning (Anslået)

22. juni 2027

Datoer for studieregistrering

Først indsendt

5. september 2026

Først indsendt, der opfyldte QC-kriterier

10. september 2026

Først opslået (Faktiske)

15. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026/05-02

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner