Minimally Invasive Right Hemicolectomy for Colorectal Disorders

(RICART Trial)

Overseen By Julia Reish

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for performing a minimally invasive right hemicolectomy, a surgery to remove part of the colon for individuals with certain colorectal issues. Researchers compare two surgical techniques: intra-corporeal anastomosis (reconnecting the intestine inside the body) and extra-corporeal anastomosis (reconnecting it outside the body). The aim is to determine which method is more effective and results in fewer complications. The trial seeks adults scheduled for this specific surgery who are not undergoing additional colon surgeries simultaneously. As an unphased trial, it offers patients the chance to contribute to improving surgical techniques and outcomes.

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.

What prior data suggests that this minimally invasive technique is safe for right hemicolectomy?

Research has shown that joining two parts of the intestine inside the body, known as intra-corporeal anastomosis, is a safe option for those undergoing minimally invasive surgery to remove part of the colon. Studies have found this method to be as safe as joining outside the body, with additional benefits.

One study found that patients who underwent the inside-the-body method experienced similar short-term results compared to those who had the outside-the-body method. Importantly, both methods had similar complication rates. Another study noted that the inside-the-body approach could even shorten hospital stays, aiding recovery.

Overall, these studies suggest that intra-corporeal anastomosis is well-tolerated and offers a safe alternative for patients considering minimally invasive colon surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intra-corporeal anastomosis in right hemicolectomy because it offers a minimally invasive approach that could enhance recovery for patients with colorectal disorders. Unlike traditional extra-corporeal methods, where the bowel is brought outside the body for reconnection, intra-corporeal anastomosis is performed internally. This technique may reduce surgical trauma, lower the risk of complications, and lead to quicker recovery times. By keeping the procedure within the body, there's potential for less pain and faster return to normal activities, which is why it's generating interest in the medical community.

What evidence suggests that intra-corporeal anastomosis is effective for colorectal disorders?

This trial will compare two techniques for minimally invasive right hemicolectomy: the internal connection technique (Intra-Corporeal Anastomosis) and the external connection technique (Extra-Corporeal). Research has shown that the internal connection technique can lead to faster recovery and fewer complications than the external connection technique. One study found that only 7.8% of patients using the internal method required additional surgeries, compared to 14.7% with the external method. Another analysis demonstrated that the internal technique significantly reduced overall complications and infection rates. It also lowered the risk of postoperative ileus, a condition where the bowel doesn't function properly after surgery. Overall, evidence suggests that the internal connection method could be a more effective option for a quicker and safer recovery. ^{1 6 7 8 9}

Who Is on the Research Team?

James Ogilvie, MS

Principal Investigator

Spectrum Health Hospitals

Are You a Good Fit for This Trial?

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.

I had a loop ileostomy along with right side colon removal.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38850445/

A retrospective cohort study of intra-corporeal versus extra- ... ICA in laparoscopic right hemicolectomy is associated with quicker post-operative recovery and may be more cost effective compared with ECA, despite increased ...

2. link.springer.com link.springer.com/article/10.1007/s10151-024-02944-0

A retrospective cohort study of intra-corporeal versus extra ... Laparoscopic right hemicolectomy has been demonstrated to result in quicker recovery and reduced complications, with comparable ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6748053/

Intracorporeal versus extracorporeal anastomosis in ... The rate of reoperation in the intracorporeal anastomosis group was 7.8%, whereas in the extracorporeal anastomosis group it was 14.7%. Of these cases, two ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1091255X24002956

Review Article Intracorporeal Versus Extracorporeal Colo- ... The cumulative results of 8 included studies with 750 patients demonstrated a significant benefit of IA over EA in terms of overall morbidity, SSI, length of ...

5. karger.com karger.com/dsu/article/41/5-6/224/913823/Intracorporeal-versus-Extracorporeal-Anastomosis

Intracorporeal versus Extracorporeal Anastomosis in ... However, the intracorporeal anastomosis group had significantly lower rates of postoperative ileus (RR 0.67, 95% CI: 0.45–0.99, p = 0.04, I2 = ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1743919110001676

Intracorporeal Anastomosis in Right Hemicolectomy The ICA offers a comparable, safe alternative to ECA in laparoscopic right hemicolectomy. Reduced hospital stay is an added advantage.

7. link.springer.com link.springer.com/article/10.1007/s00384-025-04882-1

Short-term outcomes for intracorporeal vs. extracorporeal ... The purpose of this study is to compare short-term outcomes and 1-year incisional hernia rates between intracorporeal anastomosis (IA) and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1015958425020378

Current status of totally laparoscopic left hemicolectomy ... Numerous studies have confirmed that laparoscopic procedures offer superior therapeutic outcomes compared to traditional open surgery, improving ...

9. coloproctol.org coloproctol.org/journal/view.php?doi=10.3393/ac.2021.00983.0140

a retrospective cohort study of anastomotic complications Short- and long-term outcomes of intracorporeal versus extracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for colon cancer. Surg ...