Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

ConditionsRectal Cancer Surgery Perfusion Imaging Anastomosis, Leaking

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorNingbo Medical Center Lihuili Hospital

About this trial

Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Proximal bowel blood perfusion will be measured using Laser Speckle Contrast Imaging, and the perfusion characteristics will be compared between the two ligation groups.

Additionally, for participants randomized to the LT group, an embedded prospective cohort sub-study will be performed. This sub-study involves controlled, temporary intraoperative occlusion of the preserved Left Colic Artery (LCA). During this temporary occlusion, LSCI will be used to assess the resulting changes in colonic perfusion, specifically measuring outcomes like the ischemic demarcation line (LOD) retraction distance, to further investigate the functional contribution of the preserved LCA. The overall trial aims to determine the optimal IMA ligation strategy based on objective perfusion data and a deeper understanding of LCA's role.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a confirmed diagnosis based on pathological reports;

patients who had not received any prior treatment;

Disqualifiers

a history of previous abdominal surgery or neoadjuvant chemotherapy/radiation affecting bowel perfusion or anastomosis;

patients requiring emergency surgery due to acute complications;

intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.

Trial design

Design model

Parallel

Treatments tested in this trial

High Tie of Inferior Mesenteric Artery
Procedure/Surgery
IMA was ligated approximately 1 cm from its origin after dissection of the surrounding tissue to ensure clear visualization of the IMA root. Using this technique, the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas
Low Tie of Inferior Mesenteric Artery
Procedure/Surgery
During this procedure, the LCA was identified and preserved, and the superior rectal artery was ligated. Before colonic transection or anastomosis, the preserved LCA underwent temporary, controlled occlusion. After assessing perfusion changes using LSCI, the occlusion was released to restore blood flow.

Treatment groups

143 Participants

are divided into 2 treatment groups

Group A: HT GroupExperimental treatment 1 intervention

Group B: LT GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum Perfusion Distance (MPD)

Determined by measuring the distance from the ischemic line of demarcation to the starting point of the sigmoid colon.

Time frame

Perioperative

Secondary outcomes

Number of participants requiring revision of the planned bowel transection line following intraoperative Laser Speckle Contrast Imaging (LSCI)-based bowel perfusion assessment

This measure quantifies the number of participants whose planned bowel transection line, initially determined by conventional intraoperative assessment (e.g., visual inspection, serosal sheen, peristalsis, mesenteric pulse palpation), is revised after LSCI is used to assess bowel perfusion. Revisions occur under two conditions: 1. The initial transection line was planned distal to the Line of Demarcation (LOD) indicated by LSCI, and the surgeon adjusts the transection line based on the LSCI findings (typically moving it proximally). 2. The initial transection line was planned proximal to the LSCI-indicated LOD, but the surgeon determines it must be moved distally to ensure a tension-free anastomosis. If the initial transection line is proximal to the LSCI LOD and bowel length is sufficient for a tension-free anastomosis, no revision is counted. Data will be reported as the total count and percentage of participants who meet the revision criteria.

Time frame

Perioperative

Speckle Flow Index (SFI) at the Proximal Anastomosis Site Measured by Laser Speckle Contrast Imaging (LSCI)

This measure reports the microvascular blood perfusion at the planned proximal bowel anastomosis site, assessed intraoperatively using Laser Speckle Contrast Imaging (LSCI) and SIM BFI Software (V2.0). The metric used is the Speckle Flow Index (SFI), a numerical value calculated by the software. The SFI quantifies the relative speed of red blood cells in the tissue, derived from 50 consecutive image frames with a 10 ms exposure time. While LSCI also generates real-time 2D perfusion maps for visual guidance, this measure focuses on the SFI value alone. The SFI is reported as a numerical value, typically in arbitrary perfusion units (APU) or relative units. Statistical analysis will summarize these SFI values across participants, reporting measures such as mean, median, and standard deviation.

Time frame

Perioperative

Ischemic Demarcation Line (LOD) Retraction Distance

This outcome measure will be assessed exclusively in participants randomized to the LT group. Before temporarily occluding the preserved LCA, the initial LOD will be identified using LSCI and marked. Then, the LCA will be temporarily occluded using a non-damaging vascular clamp. LSCI will be used again to visualize colonic perfusion and identify the new LOD. The LOD retraction distance is defined as the proximal distance along the bowel from the previously established reference point to the new LOD identified via LSCI. This measurement will be recorded in centimeters (cm).

Time frame

Perioperative

Other outcomes

Intraoperative blood loss

Total blood lost during surgery, calculated as suctioned volume plus gauze weight change, recorded in milliliters (ml).

Time frame

Perioperative

Operative time

Duration of the surgical procedure, from skin incision to wound closure, recorded in minutes.

Time frame

Perioperative

Intraoperative blood transfusion

Occurrence of blood transfusion during surgery, recorded as Yes/No.

Time frame

Perioperative

Postoperative surgical complications

Graded using the Clavien-Dindo classification system from the end of surgery until hospital discharge.

Time frame

Perioperative

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningbo Medical Center Lihuili Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: