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Colon CancerNCT05713903

Laparoscopic Versus Open Right Colectomy for Right Colon Cancer

A study testing Laparoscopic right colectomy and Open right colectomy in people with Colon Cancer, run by Larissa University Hospital at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Colon Cancer
What is being tested?
Laparoscopic right colectomy and Open right colectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteGreece
Study dates
6 Feb 2023to 10 Jan 2028
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed right colon cancer (cecum, ascending colon, hepatic flexure)
  • Surgical resection based on the CME principles
  • Patient 18 to 90 years old
  • American Society of Anesthesiologists score ≤III
  • Τ≤3
  • Elective operation
  • Signed informed consent of the patient

Who cannot join

  • Non elective operation (hemorrhage, perforation, obstruction)
  • Locally advanced disease (T4)
  • Distant metastases (Stage IV)
  • American Society of Anesthesiologists ≥IV
  • Previous laparotomy
  • BMI >35 kg/m2
Show all 11Show fewer
  • Active sepsis or systemic infection
  • Untreated physical and mental disability
  • Pregnancy or breast-feeding
  • Lack of compliance with the protocol process
  • Non-granting of signed informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Konstantinos Perivoliotis, MD contact

2413501000 ext. 0030

kperi19@gmail.com

George Tzovaras, Prof contact

2413502804 ext. 0030

gtzovaras@hotmail.com

Greece1 site, 1 recruiting
  • Department of Surgery, University Hospital of Larissa

    Larissa, 41110

    Konstantinos Perivoliotis, MD, 00302413501000, kperi19@gmail.com

    George Tzovaras, Professor, 00302413502804, gtzovaras@hotmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Comparison of Laparoscopic Versus Open Right Colectomy for Right Colon Cancer, According to the Complete Mesocolic Excision (CME) Principles: a Prospective Randomized Controlled Trial

The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. The comparison of the two techniques will include endpoints regarding the quality characteristics of the specimens and the oncological results. In addition, the effectiveness of the two methods will be evaluated in terms of the early and late postoperative period.

Read the detailed description

Colorectal cancer is the third and second most common malignancy in male and female patients, respectively, with up to 1.8 million new cases and 860,000 deaths per year.

Anterior resection with total mesorectal excision (TME) was first proposed by Heald in 1982 and is currently the gold standard surgical technique for middle and lower rectal cancer. Heald considered that the metastatic spread of the tumor occurs through micro-implantations in the lymph node network of the mesorectum, and much less through horizontal intramural infiltration, and thus defined rectal resection margins at 5cm or even 2cm for well-differentiated neoplasms. Therefore, he suggested that mesorectum displays a greater risk for micro-metastatic disease and should be removed en-bloc with intact resection margins.

Similarly in 2009, Hohenberger proposed the complete mesocolon excision (CME) concept for the treatment of colon cancer, based on the respective embryological development anatomical planes. After analyzing a large cohort of patients, he concluded that this operation type leads to a significant reduction in the local recurrence and an increase in the overall survival rates.

Hohenberger proposed open CME as the optimal surgical technique for colon cancer, under the premise that the following principles are met:

  • Dissection of Toldt's fascia and mesocolon preservation
  • Central vascular ligation
  • Extensive locoregional lymph node dissection CME technique, as described by Hohenberger in 2008, is an extension of Heald's TME and it is based on the sharp dissection and separation of the visceral fascia that surrounds the colon from the parietal fascia. The aim is to fully mobilize the colon and the corresponding mesocolon, which is surrounded bilaterally by sheets of visceral fascia. This ensures the complete resection of the tumor and the corresponding lymph nodes. At the same time, central vascular ligation allows the dissection of the apical lymph nodes.

There are three resection planes: the mesocolic, intramesocolic and muscularis propria plane. The ideal resection plane is the mesocolic, in which the colon is removed, along with the entire mesocolon and all the venous and lymphatic tissue, without violating the visceral fascia. Surgical specimens categorized into either of the other two resection planes are associated with reduced R0 resection rates and with reduced overall survival. Characteristically, the muscularis propria resection plane has been associated with up to 15% reduced survival rate compared to the mesocolic plane.

There are specific morphometric characteristics of surgical specimens that are used to assess their quality. These include tumor and proximal colon high vascular ligation distance, number of lymph nodes, length of resected small bowel and colon, and total area of the mesocolon. These characteristics are directly related to the number of harvested lymph nodes and, therefore, to overall survival.

According to initial results, CME specimens were larger in size, contained a longer length of colon, a larger mesenteric surface and a greater number of lymph nodes compared to the standard colectomy specimens. In addition, a greater distance of the tumor from the resection margins was highlighted. Specifically for right colon cancers, recent publications have shown that CME can achieve better morphometric specimen characteristics and a greater number of lymph nodes. In a recent randomized study, Di Buono et al. compared the completion of CME or not, during laparoscopic right colectomy. A significant difference was found in favor of CME, regarding the specimen length and the lymph node harvest.

Despite these, the literature evidence regarding the morphological and qualitative characteristics of laparoscopic and open CME specimens are still inconclusive. Specifically for right colectomies, in the comparative study by Gouvas et al., it was observed that the percentage of the mesocolic resection level was 100% in open colectomy, in contrast to 85.7% in the laparoscopic approach. However, this difference was not statistically significant. In a retrospective study by Ali Koc et al., no difference was found between open and laparoscopic CME in terms of specimen length, R0 resection rate and number of resected lymph nodes. A recent publication by Ali Zedan et al., argued that open CME is associated with longer specimens, larger mesenteric area, and increased resection margins. Another interesting finding was that the number of lymph nodes and the distance of the ligation site were greater in the laparoscopic CME group. However, the meta-analysis by Anania et al. failed to validate any difference between the two methods in the total number of lymph nodes. Finally, a comparative analysis of our own series of patients did not show superiority of one technique over the other in terms of resection level, specimen length and number of lymph nodes.

Additional qualitative characteristics of a colon cancer operation include operative time, intraoperative blood loss, time of bowel function recovery, length of postoperative hospital stay, postoperative complications, as well as overall survival and local recurrence rate. In a recent meta-analysis by Anania et al. applying the principles of CME to right colectomies did not affect the rates of postoperative leaks, bleeding, overall complications, and reoperations. However, CME right colectomy was associated with optimal results in terms of 3-year overall survival and 5-year disease-free survival.

Regarding the application of laparoscopy principles to CME colectomies, previous studies have confirmed that it is a technique with optimal results, such as faster postoperative recovery, shorter hospital stay, and lower morbidity. There is agreement between studies regarding the perioperative benefits of laparoscopic CME right colectomy versus the open method. According to Huang et al., the length of operative time between the two techniques was comparable. Laparoscopic right colectomy was associated with significantly lower intraoperative blood loss and faster initiation of feeding. In addition, these patients were discharged earlier compared to their counterparts in the open colectomy group. Moreover, no differences were observed in complication and local recurrence rates. These findings were also confirmed by the comparative study of Sheng et al., where the application of the minimally invasive technique resulted in lower levels of postoperative pain, and faster recovery. Accordingly, Shin et al., applying propensity score analysis, to remove possible confounding factors, in a sample of 2249 right colectomies and found that the technique is an independent predictor for 5-year disease-free survival. Pooled data from Anania et al., confirmed the superiority of laparoscopic CME in the rates of postoperative complications, intraoperative bleeding, and length of hospital stay. These are also in accordance with our own experience, where a significant benefit of the laparoscopic approach was shown in the duration of hospitalization and septic complications, at the cost of prolonged surgical time.

Conditions
Colon Cancer
Being tested
Laparoscopic right colectomy, Open right colectomy
Keywords
colon, cancer, open, laparoscopic, colectomy, right, mesocolic, excision
Medical subject headings
Colonic Neoplasms, Neoplasms

What participants receive

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

  • Laparoscopic right colectomyProcedure or surgery

    Resection of the ascending colon via a laparoscopic approach, adhering to the CME principles

  • Open right colectomyProcedure or surgery

    Resection of the ascending colon via an open approach, adhering to the CME principles

Study groups in NCT05713903
Study groupRoleWhat they receive
Laparoscopic right colectomyExperimentalIn laparoscopic right colectomy subgroup, the patient will be placed in a lithotomy position. Entrance in the peritoneal cavity will be completed via the open Hasson method. Overall, 4 ports will be used: 10mm at the umbilicus for optical entry, 12mm in the left midclavicular line below the umbilicus as the main working port, 5mm at the McBurney point, and 5mm between the umbilicus and the xiphoid process. Dissection of the peritoneal fold, under the terminal ileum, will be performed based on the medial to lateral approach. Similar to the open approach, the ileocolic vessels, as well as the right branches of the middle colic will be ligated at their origin for cecal and proximal ascending tumors. For hepatic flexure cancers, the medial colic vessels will be ligated. The ileocolic anastomosis will be completed either intracorporeally or extracorporeally, using staples or sutures.
Receives: Procedure: Laparoscopic right colectomy
Open right colectomyActive comparatorIn the open right colectomy group, the operation will start with a midline incision and dissection based on the lateral to medial approach. The lateral peritoneal fold along Toldt's line will be incised and the ascending colon will be mobilized from the retroperitoneum according to the embryological dissection planes. Dissection will continue until the anterior surface of the superior mesenteric vessels at the third duodenal part. Ileocolic and right colic vessels will be ligated at their origins. For hepatic flexure tumors, the middle colic vessels will be also ligated at their origin. The ileocolic anastomosis will be performed using an automatic stapler. The anastomosis will be completed either with staples or sutures.
Receives: Procedure: Open right colectomy

What is being measured

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

  1. Mesocolic Resection Plane

    Occurrence of Mesocolic Resection Plane. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 1 month postoperatively

Secondary outcomes (11)
  1. Open Conversion

    Occurrence of Open Conversion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: Intraoperative period

  2. Operative Time

    The total operative time will be recorded. Measurement unit: minutes

    Measured: Intraoperative period

  3. Type of Anastomosis

    Occurrence of Stapled or Handsewn Anastomosis. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: Intraoperative period

  4. Intraoperative Transfusion

    Occurrence of Intraoperative Transfusion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: Intraoperative period

  5. Postoperative Complication

    Occurrence of Postoperative Complication. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 1 month postoperatively

  6. Bowel Function Recovery

    Postoperative time until the recovery of bowel function is achieved. Measurement unit: days

    Measured: 7 days postoperatively

  7. Length of Hospital Stay

    Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria

    Measured: Maximum time frame 39 days postoperatively]

  8. Negative Resection Margin

    Occurrence of Negative Resection Margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 1 month postoperatively

  9. Local Recurrence

    Occurrence of Local Recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 5 years postoperatively

  10. Disease Free Survival

    Occurrence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 5 years postoperatively

  11. Overall Survival

    Occurrence of Overall Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

    Measured: 5 years postoperatively

Timeline

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

  1. First posted6 Feb 2023
  2. Study start6 Feb 2023
  3. Primary completion10 Jan 2027 (estimated)
  4. Study completion10 Jan 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will employ a prospective, parallel randomized-controlled design
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713903
Sponsor's protocol ID
LORC
Status last verified
Sep 2025
First submitted
26 Jan 2023
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual patient data

Publications

  • Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.

    PubMed 32133645
  • Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.

    PubMed 6751457
  • Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.

    PubMed 19016817
  • Strey CW, Wullstein C, Adamina M, Agha A, Aselmann H, Becker T, Grutzmann R, Kneist W, Maak M, Mann B, Moesta KT, Runkel N, Schafmayer C, Turler A, Wedel T, Benz S. Laparoscopic right hemicolectomy with CME: standardization using the "critical view" concept. Surg Endosc. 2018 Dec;32(12):5021-5030. doi: 10.1007/s00464-018-6267-0. Epub 2018 Oct 15.

    PubMed 30324463
  • Matsuda T, Iwasaki T, Sumi Y, Yamashita K, Hasegawa H, Yamamoto M, Matsuda Y, Kanaji S, Oshikiri T, Nakamura T, Suzuki S, Kakeji Y. Laparoscopic complete mesocolic excision for right-sided colon cancer using a cranial approach: anatomical and embryological consideration. Int J Colorectal Dis. 2017 Jan;32(1):139-141. doi: 10.1007/s00384-016-2673-8. Epub 2016 Oct 6.

    PubMed 27714518
  • Gouvas N, Pechlivanides G, Zervakis N, Kafousi M, Xynos E. Complete mesocolic excision in colon cancer surgery: a comparison between open and laparoscopic approach. Colorectal Dis. 2012 Nov;14(11):1357-64. doi: 10.1111/j.1463-1318.2012.03019.x.

    PubMed 22390358
  • West NP, Hohenberger W, Weber K, Perrakis A, Finan PJ, Quirke P. Complete mesocolic excision with central vascular ligation produces an oncologically superior specimen compared with standard surgery for carcinoma of the colon. J Clin Oncol. 2010 Jan 10;28(2):272-8. doi: 10.1200/JCO.2009.24.1448. Epub 2009 Nov 30.

    PubMed 19949013
  • Siani LM, Lucchi A, Berti P, Garulli G. Laparoscopic complete mesocolic excision with central vascular ligation in 600 right total mesocolectomies: Safety, prognostic factors and oncologic outcome. Am J Surg. 2017 Aug;214(2):222-227. doi: 10.1016/j.amjsurg.2016.10.005. Epub 2016 Nov 16.

    PubMed 27876380
  • Hurwitz EE, Simon M, Vinta SR, Zehm CF, Shabot SM, Minhajuddin A, Abouleish AE. Adding Examples to the ASA-Physical Status Classification Improves Correct Assignment to Patients. Anesthesiology. 2017 Apr;126(4):614-622. doi: 10.1097/ALN.0000000000001541.

    PubMed 28212203
  • Wang Y, Zhang C, Zhang D, Fu Z, Sun Y. Clinical outcome of laparoscopic complete mesocolic excision in the treatment of right colon cancer. World J Surg Oncol. 2017 Sep 18;15(1):174. doi: 10.1186/s12957-017-1236-y.

    PubMed 28923055
  • Feng B, Sun J, Ling TL, Lu AG, Wang ML, Chen XY, Ma JJ, Li JW, Zang L, Han DP, Zheng MH. Laparoscopic complete mesocolic excision (CME) with medial access for right-hemi colon cancer: feasibility and technical strategies. Surg Endosc. 2012 Dec;26(12):3669-75. doi: 10.1007/s00464-012-2435-9. Epub 2012 Jun 26.

    PubMed 22733200
  • Adamina M, Manwaring ML, Park KJ, Delaney CP. Laparoscopic complete mesocolic excision for right colon cancer. Surg Endosc. 2012 Oct;26(10):2976-80. doi: 10.1007/s00464-012-2294-4. Epub 2012 May 2.

    PubMed 22549374
  • Kang J, Kim IK, Kang SI, Sohn SK, Lee KY. Laparoscopic right hemicolectomy with complete mesocolic excision. Surg Endosc. 2014 Sep;28(9):2747-51. doi: 10.1007/s00464-014-3521-y. Epub 2014 Apr 10.

    PubMed 24718666
  • Di Buono G, Buscemi S, Cocorullo G, Sorce V, Amato G, Bonventre G, Maienza E, Galia M, Gulotta L, Romano G, Agrusa A. Feasibility and Safety of Laparoscopic Complete Mesocolic Excision (CME) for Right-sided Colon Cancer: Short-term Outcomes. A Randomized Clinical Study. Ann Surg. 2021 Jul 1;274(1):57-62. doi: 10.1097/SLA.0000000000004557.

    PubMed 33177355
  • Anania G, Davies RJ, Bagolini F, Vettoretto N, Randolph J, Cirocchi R, Donini A. Right hemicolectomy with complete mesocolic excision is safe, leads to an increased lymph node yield and to increased survival: results of a systematic review and meta-analysis. Tech Coloproctol. 2021 Oct;25(10):1099-1113. doi: 10.1007/s10151-021-02471-2. Epub 2021 Jun 12.

    PubMed 34120270

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic right colectomy and Open right colectomy in people with Colon Cancer, run by Larissa University Hospital at 1 site in Greece.

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 11 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 4 Sep 2025. 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 Greece. 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 Konstantinos Perivoliotis, MD (2413501000 ext. 0030, kperi19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mesocolic Resection Plane (time frame: 1 month postoperatively). 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 NCT05713903, which also lists 25 linked publications.

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 4 Sep 2025.

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