KliFo
Login
DeutschSymptomatic hemorrhoids are one of the most common anorectal diseases.
Hemorrhoidectomy is still the most frequently used surgical method in recent years, despite the development of a wide range of other surgical procedures.
Postoperative bleeding is a serious and even potentially life-threatening complication after hemorrhoidectomy. For postoperative blood control, many surgeons use an anal tamponade. However, the utility and potential drawbacks (e.g., pain) of such a procedure are controversial. Within a pilot project, 100 patients with a planned Milligan-Morgan hemorrhoidectomy were enrolled in a randomized controlled trial. During surgery, the patients were randomly assigned to one of the two treatment arms, what did mean to use a tamponade dressing at the end of the procedure, or not. The data indicated that the use of an anal tampon after hemorrhoidectomy does not reduce the postoperative bleeding but causes significantly more pain This led to the view that anal tampons should not be used routinely after hemorrhoidectomy but should be considered when specific indications justify their use.
The basic question of whether a tamponade is necessary and beneficial after hemorrhoidectomy is to be asked and answered in this comparative study. The findings obtained in the pilot project are to be verified by means of a multicenter randomized clinical trial. Within the prospective randomized controlled NoTamp study, patients after hemorrhoidectomy according to Milligan Morgan or Parks are randomly assigned to the intervention group without tamponade or the tamponade control group.
Inclusion criteria are the presence of hemorrhoids Grade III and IV with scheduled hemorrhoidectomy according to Milligan Morgan or Park's, age greater than or equal to 18 years, viability and the existence of a written consent statement from the patient.
Exclusion criteria are pregnancy (according to patient's statements), expected non-compliance with the study procedures in the opinion of the responsible physician, participation in other clinical trials where an impact on the target parameters of this clinical trial is to be expected. Also excluded are those who are in a relationship / employment relationship with the study leader or any investigator and patients with inflammatory anal diseases such as abscesses, fistulae or gangrene.
Two primary endpoints are analyzed within the meaning of a-priori ordered hypotheses. The maximum postoperative pain (NRS) within 48 h after the surgery and the occurrence of postoperative bleeding with the need for surgical revision within 7 days after the procedure are compared between the treatment groups. Secondary endpoints are postoperative pain at 6, 12, 24 and 48 h as well as after 7 days; change in pain severity from 6 h to 12 h, 24 h, 48 h and 7 days, and 24 to 48 h after the surgery; use of analgesics; lowest hemoglobin value within 7 days, and quality of life (EQ 5D) and patient satisfaction. Within the safety analysis, the occurrence of adverse events and serious adverse events is comparatively evaluated. The evidence obtained in this study is intended to be used for creating an evidence-based decision-making basis for surgeons regarding the necessity for the application of tamponade dressings after hemorrhoidectomy.
Postoperative bleeding is a serious and even potentially life-threatening complication after hemorrhoidectomy. For postoperative blood control, many surgeons use an anal tamponade. However, the utility and potential drawbacks (e.g., pain) of such a procedure are controversial. Within a pilot project, 100 patients with a planned Milligan-Morgan hemorrhoidectomy were enrolled in a randomized controlled trial. During surgery, the patients were randomly assigned to one of the two treatment arms, what did mean to use a tamponade dressing at the end of the procedure, or not. The data indicated that the use of an anal tampon after hemorrhoidectomy does not reduce the postoperative bleeding but causes significantly more pain This led to the view that anal tampons should not be used routinely after hemorrhoidectomy but should be considered when specific indications justify their use.
The basic question of whether a tamponade is necessary and beneficial after hemorrhoidectomy is to be asked and answered in this comparative study. The findings obtained in the pilot project are to be verified by means of a multicenter randomized clinical trial. Within the prospective randomized controlled NoTamp study, patients after hemorrhoidectomy according to Milligan Morgan or Parks are randomly assigned to the intervention group without tamponade or the tamponade control group.
Inclusion criteria are the presence of hemorrhoids Grade III and IV with scheduled hemorrhoidectomy according to Milligan Morgan or Park's, age greater than or equal to 18 years, viability and the existence of a written consent statement from the patient.
Exclusion criteria are pregnancy (according to patient's statements), expected non-compliance with the study procedures in the opinion of the responsible physician, participation in other clinical trials where an impact on the target parameters of this clinical trial is to be expected. Also excluded are those who are in a relationship / employment relationship with the study leader or any investigator and patients with inflammatory anal diseases such as abscesses, fistulae or gangrene.
Two primary endpoints are analyzed within the meaning of a-priori ordered hypotheses. The maximum postoperative pain (NRS) within 48 h after the surgery and the occurrence of postoperative bleeding with the need for surgical revision within 7 days after the procedure are compared between the treatment groups. Secondary endpoints are postoperative pain at 6, 12, 24 and 48 h as well as after 7 days; change in pain severity from 6 h to 12 h, 24 h, 48 h and 7 days, and 24 to 48 h after the surgery; use of analgesics; lowest hemoglobin value within 7 days, and quality of life (EQ 5D) and patient satisfaction. Within the safety analysis, the occurrence of adverse events and serious adverse events is comparatively evaluated. The evidence obtained in this study is intended to be used for creating an evidence-based decision-making basis for surgeons regarding the necessity for the application of tamponade dressings after hemorrhoidectomy.
Current timezone: Europe/Berlin