Anastomotic LeakLICOSARHNCT07132970
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
An observational study of Anastomotic Leak and Colon Cancer, run by Aesculap AG at 4 sites in Germany.
Trial summary
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- What is being tested?
- Monoplus Suture Material
- Type of treatment
- Medical device
- How many people
- 249 participants
- Where
- 4 sitesGermany
- Study dates
- 26 Jan 2026to Mar 2028
- Phase
- Observational
- 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
Study population: Patients undergoing elective, primary open or laparoscopic right hemicolectomy or right extended hemicolectomy for malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.
Who may be able to join
- Patients undergoing a primary, elective either open or laparoscopic right hemicolectomy or right extended hemicolectomy due to malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.
- Either complete hand-sewn anastomosis or partial sutured anastomosis (e.g. combination of stapling and suturing)
- Open or laparoscopic as well as conversion from open to laparoscopic surgery
- Absence of peritoneal carcinomatosis
- Absence of vascular, nervous or bone infiltration
- Age ≥ 18 years
- Written data protection declaration (Written Informed consent)
Who cannot join
- Left hemicolectomy or left extended hemicolectomy or sigma resection
- Inflammatory bowel disease (e.g. Crohn´s disease)
- Emergency surgery
- Previous abdominal surgery with bowel resection
- Re-operation of an anastomosis (anastomosis revision surgery)
- Need for stoma creation
- Non-compliant patients
- Participation in an interventional randomized controlled study (RCT)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie
Darmstadt, 64287
Guido Woeste, Prof. Dr.
- Recruiting
Alb-Fils-Klinikum Göppingen, Dept. General Surgery
Göppingen, Baden-Wurttemberg, 73035
Stefan Riedl, Prof.Dr.med
- Recruiting
Städtisches Klinikum Lüneburg, Dept. General Surgery
Lüneburg, Lower Saxony, 21339
Tobias Rose, Dr.
- Recruiting
Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery
Schwäbisch Hall, Baden-Wurttemberg, 74523
Markus Golling, Prof. Dr.
About this study
Official title: Assessment of the Leakage Rate of Ileo-colic Sutured Anastomoses Using a Polydioxanone Based Suture Material After Laparoscopic or Open Right Hemicolectomy to Treat Malignancy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.
Read the detailed description
The study will include patients with right colon cancer, treated with elective colectomy and with local curative intention, in whom primary anastomosis with no protective stoma will be performed. Right colectomy is defined as a resection of terminal 10 cm of ileum, the cecum, the ascending right colon, and right third or half of the transverse colon followed by ileo-colostomy.The anastomosis leakage rate after right-sided hemicolectomy is the most important complication, because it leads to further morbidity of the affected patients. The anastomosis leakage rate ranges between 1-10% depending on the study population (cancer patients vs. non-cancer patients) and the type of anastomosis.
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Being tested
- Monoplus Suture Material
- Medical subject headings
- Anastomotic Leak, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoplus Suture MaterialDevice
Ileocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomosis leakage
An anastomosis leak is defined as " leak of luminal contents from a anastomotic site between two hollow viscera" diagnosed (1) radiologically, by a radiographic enema with hydro soluble contrast or by computerized tomography with the presence of intra-abdominal collection adjacent to the anastomosis; (2) clinically with evidence of extravasation of bowel content or gas through a wound or drain; (3) by endoscopy, or (4) intraoperatively.
Anastomosis leak will be classified and graded according to Clavien-Dindo.
Grade I:
Anastomosis leakage requiring no active intervention (e.g. antibiotics)
Grade II:
Anastomosis leakage requiring active radiological intervention but manageable without surgical intervention.
Grade III:
Anastomosis leakage requiring surgical re-intervention.
Grade IV:
Anastomosis leakage leading to life-threatening condition requiring IC /ICU management
Grade V:
Anastomosis leakage leading to death of the patient
Measured: until 30 days postoperatively
Secondary outcomes (9)
Rate of complications
Stenosis
- bleeding
- hemmorage
- obstruction
- intradominal abszess
- ileus
- peritonitis
- sepsis
Measured: discharge, 30 days postoperatively, 1 year postoperatively
Mortality rate
Measured: 30 days postoperatively, 1 year postoperatively
Surgical Site infection rate
Superficial Surgical Site Infection and deep Surgical Site Infection rate according to CDC
Measured: 30 days and 12 months after surgery
Length of hospital stay
Measured: day of discharge after surgery
Handling of the used suture material
Different dimensions rated by the surgeon using 5-point Likert scale. (1= best to 5=worse) A 5-point Likert scale is a survey tool that allows respondents to express their level of agreement or disagreement with a statement, providing nuanced feedback through five ordered response options.
Structure of a 5-Point Likert Scale
A typical 5-point Likert scale includes the following response options:
Strongly Disagree: Indicates a firm rejection of the statement. Disagree: Shows a general opposition to the statement, but less intense than "Strongly Disagree." Neither Agree Nor Disagree: Represents a neutral position, suggesting indecision or a balanced view.
Agree: Expresses support for the statement, but not with full intensity. Strongly Agree: Demonstrates strong approval or endorsement of the statement. 2
Measured: interoperatively
Patient satisfaction
Assessment of patient satisfaction using 100 point scale (1 lowest- 100 highest satisfaction)
Measured: 30 days postoperavely, 12 months postoperatively
Quality of Life, using EQ5D5L
EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"
Measured: preoperatively, 30 day postoperatively and 12 months postoperatively
Bowel function assessment
Low Anterior Rectum Syndrome (LARS) questionnaire, assessed by the patient. The LARS Score was developed in 2012 and represents an international, validated, simple and quick instrument to assess bowel function and allows quantitative evaluation of severity of functional defects. It consists of 5 questions with a score that ranges from 0 to 42 points, with classification of patients into: no LARS (0-20), minor LARS (21-29) or major LARS (30-42 points). The five very disabling bowel symptoms of LARS score (any flatus or liquid incontinence, altered stool frequency, faecal clustering and faecal urgency) will be analysed and rated by the patients, because of their known negative influence on quality of life.
Measured: Day of discharge after surgery, 30 days postoperatively, 1 year postoperatively
Hernia rate
Hernia will be evaluated according to the EHS classification (European Hernia Society), Incisional hernia is defined as an "abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging" according to the definition to the European Hernia society
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start26 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Golling, Prof. Dr., Study chair, Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132970
- Sponsor's protocol ID
- AAG-O-H-25123
- Acronym
- LICOSARH
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2025
- Last updated
- 9 Jun 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Leakage Rate of Ileo-colic Sutured Anastomoses Using a Polydioxanone Based Suture Material After Laparoscopic or Open Right Hemicolectomy to Treat Malignancy
- ClinicalTrials.gov ID
- NCT07132970
- Acronym / sponsor ID
- LICOSARH / AAG-O-H-25123
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Aug 2025 (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.
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.
Detailed description
The study will include patients with right colon cancer, treated with elective colectomy and with local curative intention, in whom primary anastomosis with no protective stoma will be performed. Right colectomy is defined as a resection of terminal 10 cm of ileum, the cecum, the ascending right colon, and right third or half of the transverse colon followed by ileo-colostomy.The anastomosis leakage rate after right-sided hemicolectomy is the most important complication, because it leads to further morbidity of the affected patients. The anastomosis leakage rate ranges between 1-10% depending on the study population (cancer patients vs. non-cancer patients) and the type of anastomosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective, primary open or laparoscopic right hemicolectomy or right extended hemicolectomy for malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.
Key inclusion criteria (7 listed)
- Patients undergoing a primary, elective either open or laparoscopic right hemicolectomy or right extended hemicolectomy due to malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.
- Either complete hand-sewn anastomosis or partial sutured anastomosis (e.g. combination of stapling and suturing)
- Open or laparoscopic as well as conversion from open to laparoscopic surgery
- Absence of peritoneal carcinomatosis
- Absence of vascular, nervous or bone infiltration
Key exclusion criteria (8 listed)
- Left hemicolectomy or left extended hemicolectomy or sigma resection
- Inflammatory bowel disease (e.g. Crohn´s disease)
- Emergency surgery
- Previous abdominal surgery with bowel resection
- Re-operation of an anastomosis (anastomosis revision surgery)
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 |
|---|---|---|
| Monoplus Suture MaterialIleocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery | Device | – |
Primary outcome
Rate of anastomosis leakage
Time frame: until 30 days postoperatively
An anastomosis leak is defined as " leak of luminal contents from a anastomotic site between two hollow viscera" diagnosed (1) radiologically, by a radiographic enema with hydro soluble contrast or by computerized tomography with the presence of intra-abdominal collection adjacent to the anastomosis; (2) clinically with evidence of extravasation of bowel content or gas through a wound or drain; (3) by endoscopy, or (4) intraoperatively. Anastomosis leak will be classified and graded according to Clavien-Dindo. Grade I: Anastomosis leakage requiring no active intervention (e.g. antibiotics) Grade II: Anastomosis leakage requiring active radiological intervention but manageable without surgical intervention. Grade III: Anastomosis leakage requiring surgical re-intervention. Grade IV: Anastomosis leakage leading to life-threatening condition requiring IC /ICU management Grade V: Anastomosis leakage leading to death of the patient
9 secondary outcomes
Rate of complications
Time frame: discharge, 30 days postoperatively, 1 year postoperatively
Mortality rate
Time frame: 30 days postoperatively, 1 year postoperatively
Surgical Site infection rate
Time frame: 30 days and 12 months after surgery
Length of hospital stay
Time frame: day of discharge after surgery
Handling of the used suture material
Time frame: interoperatively
Patient satisfaction
Time frame: 30 days postoperavely, 12 months postoperatively
Quality of Life, using EQ5D5L
Time frame: preoperatively, 30 day postoperatively and 12 months postoperatively
Bowel function assessment
Time frame: Day of discharge after surgery, 30 days postoperatively, 1 year postoperatively
Hernia rate
Time frame: 12 months postoperatively
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Anastomotic Leak
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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.
Markus Golling, Prof. Dr. study chair
Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak and Colon Cancer, run by Aesculap AG at 4 sites in Germany.
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 7 inclusion and 8 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 Petra Baumann, Dr. (+497461-95 ext. 0, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomosis leakage (time frame: until 30 days postoperatively). 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 9 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.