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Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost 10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS) program has proven its effectiveness in elective surgery and can theoretically improve outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to investigate the safety and efficacy of a modified ERAS protocol in LA.
A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing, limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics; low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of stay (pLOS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified ERAS protocol group | Experimental | Laparoscopic appendectomy with modified ERAS protocol group Preadmission. Not available due to the emergency setting. Preoperative care. 1) Patient brochure with a detailed description of the type of pathology, surgery procedure, rehabilitation process, possible complications, and other. Surgery.
Postoperative care.
|
|
| Standard care group | Placebo Comparator | Standard care laparoscopic appendectomy. Preadmission. Not available due to emergency setting. Preoperative care. 1) Patient oral informing about the type of pathology, surgery procedure and possible complications. No brochure. Surgery.
1) Mobilization in 4-6 h after surgery 2) Fluid intake in 6 hours 3) Liquid food intake in 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic appendectomy | Procedure | Preoperative care in both arms. Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. Surgery. General anesthesia with strict control of fluid therapy and hemodynamic changes during surgery. Appendectomy with the use of monopolar coagulation by experienced surgeons following appendix stump ligation by two Roeder knots. Postoperative care. Antibiotics for 3-5 days for patients with complicated appendicitis (Gomez ≥ 3A). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 2, 6, 12 and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative length of stay (pLOS) | Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage | 30 days |
| Readmission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander V Sazhin, Prof. | Pirogov Russian National Research Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taras Nechay | Moscow | 115569 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33047586 | Derived | Sazhin AV, Nechay TV, Titkova SM, Petukhov VA, Tyagunov AE, Stradymov EA, Ermakov IV, Mishakina NY. [Appendectomy technique: paradigm shift or a well-forgotten old one? The role of mesoappendectomy in prevention of infectious intra-abdominal complications (announcement of RCT)]. Khirurgiia (Mosk). 2020;(10):49-59. doi: 10.17116/hirurgia202010149. Russian. | |
| 32612104 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2021 | |
| Reset | Feb 3, 2021 | |
| Release | May 1, 2021 | |
| Reset | May 24, 2021 | |
| Release | Jun 11, 2025 | |
| Reset | Jun 27, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2021 | Feb 3, 2021 | |||
| May 1, 2021 |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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|
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage |
| 30 days |
| Postoperative pain | Level of postoperative pain syndrome measured with a visual analog scale in centimeters | 24 hours |
| Shoulder pain incidence | Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage | 24 hours |
| Shoulder pain level | Level of shoulder pain syndrome measured with visual analog scale in centimeters | 24 hours |
| Nechay T, Sazhin A, Titkova S, Tyagunov A, Anurov M, Melnikov-Makarchuk K, Tyagunov A. Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study. Sci Rep. 2020 Jul 1;10(1):10749. doi: 10.1038/s41598-020-67591-5. |
| May 24, 2021 |
| Jun 11, 2025 | Jun 27, 2025 |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |