Minimally Invasive Right Hemicolectomy for Colorectal Disorders

(RICART Trial)

Overseen By Julia Karum

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spectrum Health Hospitals

Disqualifiers: Pregnancy, Additional colon resection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery date

125 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is intracorporeal anastomosis safe for humans in minimally invasive right hemicolectomy?

Research shows that intracorporeal anastomosis, used in minimally invasive right hemicolectomy, is generally considered safe from both technical and cancer-related perspectives. Studies have compared it to extracorporeal anastomosis and found it to be a viable option with potential benefits in surgical outcomes. ^{1 2 3 4 5}

How does the treatment Intra-Corporeal Anastomosis differ from other treatments for colorectal disorders?

Intra-Corporeal Anastomosis (ICA) is a technique used during minimally invasive right hemicolectomy where the connection between the intestines is made inside the body, unlike the extracorporeal method where it is done outside. This approach may offer benefits such as reduced recovery time and fewer complications, but its advantages over the extracorporeal method are still debated. ^{4 5 6 7 8}

What is the purpose of this trial?

Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Research Team

James Ogilvie, MS

Principal Investigator

Spectrum Health Hospitals

Eligibility Criteria

This trial is for adults over 18 who need a right hemicolectomy, which is surgery to remove part of the colon, using minimally invasive methods. It's not for prisoners, those unable to consent, emergency cases, pregnant women or if additional colon resection like left colectomy is planned.

Exclusion Criteria

My surgery is planned at Butterworth hospital.

I am scheduled for further surgery on my colon.

Emergent cases

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a right hemicolectomy via a minimally invasive approach with intra-corporeal or extra-corporeal anastomosis

Surgery date

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for return of bowel function and other secondary outcomes such as surgical site infection and postoperative narcotic use

up to 2 weeks

Daily monitoring during hospital stay

Follow-up

Participants are monitored for surgical site infection and perioperative morbidity

up to 6 weeks

Treatment Details

Interventions

• Intra-Corporeal Anastomosis

Trial Overview The study tests whether creating an anastomosis (connection between two parts of the intestine) inside the body after a right hemicolectomy leads to faster bowel function recovery and earlier hospital discharge compared to other methods.

Participant Groups

Group I: Intra-corporeal Experimental Treatment 1 Intervention

Right Hemicolectomy

Group II: Extra-corporeal Experimental Treatment 1 Intervention

Right Hemicolectomy

Intra-Corporeal Anastomosis is already approved in European Union, United States, China for the following indications:

Approved in European Union as Intracorporeal Anastomosis for:

• Right hemicolectomy
• Colorectal surgery

Approved in United States as Intracorporeal Anastomosis for:

• Right hemicolectomy
• Colorectal surgery

Approved in China as Intracorporeal Anastomosis for:

• Right hemicolectomy
• Colorectal surgery

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Findings from Research

Intracorporeal anastomosis (IA) during laparoscopic right hemicolectomy resulted in less intraoperative blood loss and shorter incision length compared to extracorporeal anastomosis (EA), indicating a potentially safer and less invasive approach.

Patients who underwent IA experienced faster recovery, with earlier postoperative bowel function and lower pain scores, while the overall complication rates were similar between IA and EA, suggesting IA may enhance patient comfort and recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative and postoperative short-term outcomes of intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. Zhou, Y., Zhou, Y., Wang, C., et al.[2023]

In a study comparing 48 patients undergoing robotic-assisted intracorporeal anastomosis to 48 patients with standard extracorporeal anastomosis, the robotic group experienced significantly fewer complications, with no anastomotic complications or incisional hernias reported.

Patients in the robotic group also had a quicker recovery, with bowel function returning faster and a shorter hospital stay, indicating that robotic-assisted techniques may enhance postoperative outcomes in right hemicolectomy for cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy for cancer: a case control study. Morpurgo, E., Contardo, T., Molaro, R., et al.[2022]

In a study of 162 patients undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis, the procedure demonstrated a low mortality rate of 2.5% and acceptable operating time of 100 minutes, indicating it is a safe surgical option.

The oncological outcomes were promising, with a 100% rate of complete resection and low local recurrence (0.8%) after a median follow-up of 2.5 years, suggesting that this technique is effective for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Totally laparoscopic right hemicolectomy with intracorporeal anastomosis is a technically and oncologically safe procedure. Kornmann, VN., Hagendoorn, J., van Koeverden, S., et al.[2014]

In a study of 173 patients undergoing laparoscopic right hemicolectomy with intracorporeal ileocolic anastomosis, the procedure demonstrated a safety profile with a complication rate of 22.54% and a conversion rate of 9.2%.

The intracorporeal approach is a feasible alternative to extracorporeal anastomosis, potentially reducing some associated drawbacks while maintaining similar complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracorporeal ileocolic anastomosis in patients with laparoscopic right hemicolectomy. Abrisqueta, J., Ibañez, N., Luján, J., et al.[2019]

Intracorporeal anastomosis (ICA) in minimally invasive right hemicolectomy significantly reduces the incidence of postoperative paralytic ileus and results in shorter incision lengths compared to extracorporeal anastomosis (ECA), based on a meta-analysis of 7 randomized controlled trials involving 750 patients.

However, ICA is associated with a longer operative time, indicating a trade-off between reduced complications and increased duration of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta‑analysis of randomized controlled trials comparing intracorporeal versus extracorporeal anastomosis in minimally invasive right hemicolectomy: upgrading the level of evidence. Zhang, T., Sun, Y., Mao, W.[2023]

In a study of 85 patients undergoing laparoscopic right hemicolectomy, intracorporeal anastomosis (IA) resulted in significantly longer operation times (154 minutes) compared to extracorporeal anastomosis (EA) (95 minutes), but showed no mortality and a shorter hospital stay (5.3 days) versus EA (11.2 days).

The rate of reoperation was lower in the IA group (7.8%) compared to the EA group (14.7%), suggesting that IA may be a safer option for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy - single center experience. Kwiatkowski, AP., Stępińska, G., Stanowski, E., et al.[2022]

In a study of 197 patients who underwent laparoscopic right hemicolectomy for malignant disease, the intracorporeal anastomosis (ICA) technique resulted in significantly fewer non-surgical complications compared to the extracorporeal anastomosis (ECA) technique (10% vs. 31%).

The ICA group also had a lower incidence of wound infections (2% vs. 12%) and a significantly reduced risk of incisional hernias over a five-year follow-up period (1% vs. 8%), indicating better long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracorporeal anastomosis versus extracorporeal anastomosis after laparoscopic right hemicolectomy for colon cancer: morbidity comparison at long-term follow-up. Veneroni, S., Palini, GM., Pirrera, B., et al.[2022]

Intracorporeal ileocolic anastomosis (IA) during laparoscopic right hemicolectomy for colon cancer showed no significant difference in short- and long-term outcomes compared to extracorporeal anastomosis (EA), based on a study of 86 patients.

The IA technique had a lower conversion rate to open surgery (0% vs. 8.6% in EA), suggesting it may be a safer option, while both techniques had similar rates of complications and overall survival after 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term outcomes of intracorporeal versus extracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for colon cancer. Lee, KH., Ho, J., Akmal, Y., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative and postoperative short-term outcomes of intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Robotic-assisted intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy for cancer: a case control study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Totally laparoscopic right hemicolectomy with intracorporeal anastomosis is a technically and oncologically safe procedure. [2014]

4. Germany pubmed.ncbi.nlm.nih.gov

Intracorporeal ileocolic anastomosis in patients with laparoscopic right hemicolectomy. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Meta‑analysis of randomized controlled trials comparing intracorporeal versus extracorporeal anastomosis in minimally invasive right hemicolectomy: upgrading the level of evidence. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

Intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy - single center experience. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Intracorporeal anastomosis versus extracorporeal anastomosis after laparoscopic right hemicolectomy for colon cancer: morbidity comparison at long-term follow-up. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Short- and long-term outcomes of intracorporeal versus extracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for colon cancer. [2021]