Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate the effect of gastrointestinal stimulation with a pacemaker on the length of postoperative bowel paralysis in patients undergoing major abdominal surgery due to metastasizing colorectal cancer, appendiceal cancer or pseudomyxoma peritonei.
The main question it aims to answer is if the length of postoperative ileus is reduced when the gastrointestinal tract is stimulated with a pacemaker.
All participants will undergo cytoreductive surgery +/- heated intraperitoneal chemotherapy (the standard treatment for colorectal cancer, appendiceal cancer with peritoneal carcinomatosis or pseudomyxoma peritonei). After surgery, but before the abdomen is closed a pace lead will be attached to the stomach, exteriorized trough the abdominal wall and connected to an external pacemaker. The pacemaker is either turned on (experimental group) or off (control group).
After surgery, patients will be asked to fill out a diary on bowel movements once a day. Once normal bowel function is regained, the pace lead and pacemaker will be removed trough the abdominal wall with a firm pull.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is set to the following settings: 10,5 Volt, 14 hz, 330 Micro sec, Cycling 5 seconds off 0,1 sec on. The pacemaker is turned on. |
|
| Control group | Sham Comparator | A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric electrical stimulation | Device | Mounting of a temporary gastric pacemaker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from surgery till first stool | Daily patient diary information regarding stool and flatus | Approx. 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Whole gut and regional transit times | Measured with the SmartPill | Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days |
| Length of hospital stay | Number of days from primary surgery to hospital discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne K Martensen, MD | Contact | +45 30595095 | anmate@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jonas Funder, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| approx 14 days |
| Medical complications | Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications | approx 14 days |
| Surgical complications including anastomotic leakage | Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage | approx 14 days |
| Need for surgical or radiological interventions | The number of times and the surgical or radiological procedure performed | approx 14 days |
| Re-hospitalization within 30 days | The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery | From day of surgery + 30 days |
| Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated | In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy | From day of surgery +90 days |
| 90-day mortality | Mortality within 90 days of primary surgery | From day of surgery +90 days |